A Trial to Investigate Efficacy, Safety and Tolerability of FE 201836 for Nocturia Due to Nocturnal Polyuria in Adults

February 17, 2022 updated by: Ferring Pharmaceuticals

A Randomised, Double-blind, Placebo-controlled, Response-adaptive Dose-finding Trial Investigating the Efficacy, Safety and Tolerability of Oral Doses of FE 201836, With Desmopressin Orally Disintegrating Tablet as a Benchmark, During 12 Weeks of Treatment for Nocturia Due to Nocturnal Polyuria in Adults

The purpose of this trial was to investigate the efficacy, safety and tolerability of different oral doses of FE 201836, with desmopressin as a benchmark, during 12 weeks of treatment for nocturia due to nocturnal polyuria in adults

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
302

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium
        • ULB Hopital Erasme
      • Edegem, Belgium
        • UZ Antwerpen
      • Gent, Belgium
        • Universitair Ziekenhuis Gent
      • Kortrijk, Belgium
        • AZ Groeninge - Campus Vercruysselaan
      • Leuven, Belgium
        • UZ Leuven
  • Canada
      • London, Canada
        • Milestone Research
      • Newmarket, Canada
        • SKDS Research Inc.
      • Quebec, Canada
        • Diex Recherche Quebec Inc.
      • Québec, Canada
        • Clinique Médicale St-Louis (Recherche) inc d/b/a/ Centre de Recherche Saint-Louis
      • Sarnia, Canada
        • Bluewater Health-Norman Site
      • Sherbrooke, Canada
        • CHUS - Hôpital Fleurimont
      • Sherbrooke, Canada
        • DIEX Recherche Sherbrooke Inc.
      • Toronto, Canada
        • Ferring Investigational Site
      • Victoriaville, Canada
        • Diex Recherche Victoriaville Inc.
    • Quebec
      • Pointe-Claire, Quebec, Canada
        • Ultra-Med Inc.
  • Czechia
      • Benešov, Czechia
        • Urologie Benešov - Afimed s.r.o.
      • Brno, Czechia
        • Fakultni nemocnice Brno, Dept of Klinika nemoci plicnich a tuberkulozy
      • Liberec, Czechia
        • Krajska nemocnice Liberec, a.s.
      • Plzen, Czechia
        • Urocentrum Plzen
      • Praha, Czechia
        • Thomayerova nemocnice, PARENT
  • Germany
      • Duisburg, Germany
        • Gemeinschaftspraxis fuer Urologie und Andrologie
      • Emmendingen, Germany
        • Urologische Gemeinschaftspraxis
      • Weiden, Germany
        • Klinikum Weiden, Klinik f. Urologie, Andrologie und Kinderurologie
  • Hungary
      • Budapest, Hungary
        • Jahn Ferenc Del-pesti Korhaz es Rendelointezet
      • Budapest, Hungary
        • Synexus Magyarorszag Kft.
      • Kecskemet, Hungary
        • Bagoly Egeszseghaz
      • Nyiregyhaza, Hungary
        • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz Urologia
      • Szolnok, Hungary
        • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelőintézet
  • Poland
      • Bydgoszcz, Poland
        • Nasz Lekarz Osrodek Badan Klinicznych
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Achieve Clinical Research, LLC
      • Mobile, Alabama, United States, 36608
        • Coastal Clinical Research, an AMR company
    • California
      • Lincoln, California, United States, 95648
        • Clinical Trials Research
      • Murrieta, California, United States, 92562
        • Tri Valley Urology Medical Group
      • San Diego, California, United States, 92120
        • San Diego Clinical Trials
      • Westminster, California, United States, 92683
        • Advanced Rx Clinical Research Group, Inc.
    • Colorado
      • Denver, Colorado, United States, 80209
        • Downtown Women's Health Care
      • Denver, Colorado, United States, 80220
        • Genitourinary Surgical Consultants, P.C.
    • Florida
      • Aventura, Florida, United States, 33180
        • South Florida Medical Research
      • Clearwater, Florida, United States, 33761
        • Tampa Bay Medical Research, Inc.
      • Clearwater, Florida, United States, 33759
        • Women's Medical Research Group, LLC
      • Coral Gables, Florida, United States, 33134
        • Clinical Research of South Florida
      • DeLand, Florida, United States, 32720
        • Avail Clinical Research, LLC
      • Greenacres City, Florida, United States, 33467
        • Finlay Medical Research Corp
      • Miami, Florida, United States, 33126
        • Pharmax Research Clinic
      • Miami, Florida, United States, 33155
        • Sanitas Research
      • Miami, Florida, United States, 33145
        • Doctors Research Institute Corporation
      • New Port Richey, Florida, United States, 34655
        • Bayside Clinical Research LLC
      • Pembroke Pines, Florida, United States, 33026
        • Pines Care Research Center, Inc
      • Pompano Beach, Florida, United States, 33060
        • Clinical Research Center of Florida
      • Saint Petersburg, Florida, United States, 33709
        • Meridien Research, Inc.
    • Indiana
      • Avon, Indiana, United States, 46123
        • American Health Network of Indiana, LLC
      • Greenfield, Indiana, United States, 46140
        • American Health Network of Indiana, LLC
    • Massachusetts
      • Watertown, Massachusetts, United States, 02472
        • Bay State Clinical Trials, Inc.
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
        • Beyer Research
      • Rochester, Michigan, United States, 48307
        • Remedica LLC
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Quality Clinical Research Center, Inc.
    • Nevada
      • Las Vegas, Nevada, United States, 89119-5190
        • Clinical Research Consortium, an AMR company
    • New York
      • New Windsor, New York, United States, 12553
        • Mid Hudson Medical Research, PLLC
      • Poughkeepsie, New York, United States, 12601
        • Premier Medical Group of the Hudson Valley, PC
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • American Health Research, Inc.
      • Greensboro, North Carolina, United States, 27408
        • Medication Management, LLC
      • High Point, North Carolina, United States, 27262
        • Peters Medical Research
      • Raleigh, North Carolina, United States, 27609
        • PMG Research of Raleigh, LLC
      • Wilmington, North Carolina, United States, 28401
        • PMG Research of Wilmington, LLC
    • Ohio
      • Englewood, Ohio, United States, 45322
        • HWC Women's Research Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02908
        • NECCR Primacare Research, LLC
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • PMG Research of Charleston, LLC
      • Mount Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research Center, Inc
    • Texas
      • Houston, Texas, United States, 77079
        • MCA Research - Partner
    • Utah
      • Clinton, Utah, United States, 84015
        • Ericksen Research & Development, LLC
      • Ogden, Utah, United States, 84405
        • Advanced Research Institute
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Clinical Research Associates of Tidewater, an AMR company

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults ≥18 years of age (at the time of written consent)
  • Medical history of, or subject reported nocturia symptoms during the 6 months prior to Visit 1
  • ≥2 nocturnal voids (an average over 3 days) as documented in the 3-day e-Diary prior to Visit 2
  • The largest single voided volume must be ≥200 mL (at least 1 void ≥200 mL) as documented in the 3-day e-Diary prior to Visit 2
  • Nocturnal polyuria, defined as Nocturnal Polyuria index >33%, a ratio of Nocturnal Urine Volume in excess of 33% of total daily (24-hour) urine volume as documented in the 3-day e-Diary prior to Visit 2
  • ≥20% decrease in the nocturnal diuresis rate (mL/min) (that was recorded at Visit 2) as documented in the 3-day e-Diary prior to Visit 3

Exclusion Criteria:

  • Current diagnosis of Obstructive Sleep Apnoea (OSA)
  • Restless Legs Syndrome (RLS)
  • Bladder Outlet Obstruction (BOO) or urine flow <5 mL/s, as confirmed by uroflowmetry upon suspicion during screening prior to Visit 2
  • Urinary incontinence defined as an average of >1 episode/day in the 3-day e-Diary prior to Visit 2 (occasional urge incontinence during daytime or at night on the way to void is not necessarily exclusionary)
  • Any pelvic or lower urinary tract surgery and/or radio therapy or previous pelvic irradiation within the past 6 months prior to Visit 1. Including e.g., transurethral resection for Bladder Outlet Obstruction or Benign Prostatic Hyperplasia, hysterectomy or female incontinence procedures
  • Genito-urinary tract pathology that can in the investigator's opinion be responsible for urgency or urinary incontinence e.g., symptomatic or recurrent urinary tract infections, interstitial cystitis, bladder-related pain, chronic pelvic pain syndrome, or stone in the bladder or urethra causing symptoms
  • A history of cancer with the last date of disease activity/presence of malignancy within the last 12 months prior to Visit 1, except for adequately treated basal cell carcinoma of the skin
  • History of any neurological disease affecting bladder function or muscle strength (e.g., Multiple Sclerosis, Parkinson's, spinal cord injury, spina bifida)
  • Habitual (fluid intake >3L per day) or psychogenic polydipsia
  • Uncontrolled hypertension, as judged by the investigator
  • Uncontrolled diabetes mellitus, as judged by the investigator
  • Central or nephrogenic diabetes insipidus
  • Known history of Syndrome of Inappropriate Antidiuretic Hormone (SIADH) secretion
  • History of gastric retention
  • Suspicion or evidence of congestive heart failure, (New York Heart Association (NYHA) class II, III, IV)

  • Hyponatraemia:

    • Serum sodium level <135 mmol/L at Visit 1(re-tested, with results available within 7 days)
    • Serum sodium level <130 mmol/L at Visit 3 (re-tested, with results available within 7 days)

  • Use of any prohibited therapy listed below:

    • Current or former (within 3 months prior to screening) treatment with any other investigational medicinal product (IMP)
    • Unstable electrostimulation or behavioural bladder training program less than 3 months prior to screening (stable electrostimulation or behavioural bladder training program started at least 3 months before screening are acceptable)
    • Thiazide diuretics
    • Antiarrhythmic agents
    • V2-receptor antagonists/agonists (e.g., vaptans/desmopressin, vasopressin)
    • Loperamide
    • Botulinum toxin (cosmetic non-urological use is acceptable)
    • Valproate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FE 201836 500 μg (Randomized Treatment Period)
FE 201836 500 μg oral solution and placebo orally disintegrating tablet (ODT), administered once daily
Drug: FE 201836
Oral solution for daily intake
Other Names:
  • Velmupressin
Drug: Placebo ODT
Manufactured to mimic experimental drug
Experimental: FE 201836 350 μg (Randomized Treatment Period)
FE 201836 350 μg oral solution and placebo ODT, administered once daily
Drug: FE 201836
Oral solution for daily intake
Other Names:
  • Velmupressin
Drug: Placebo ODT
Manufactured to mimic experimental drug
Experimental: FE 201836 250 μg (Randomized Treatment Period)
FE 201836 250 μg oral solution and placebo ODT, administered once daily
Drug: FE 201836
Oral solution for daily intake
Other Names:
  • Velmupressin
Drug: Placebo ODT
Manufactured to mimic experimental drug
Experimental: FE 201836 150 μg (Randomized Treatment Period)
FE 201836 150 μg oral solution and placebo ODT, administered once daily
Drug: FE 201836
Oral solution for daily intake
Other Names:
  • Velmupressin
Drug: Placebo ODT
Manufactured to mimic experimental drug
Experimental: FE 201836 100 μg (Randomized Treatment Period)
FE 201836 100 μg oral solution and placebo ODT, administered once daily
Drug: FE 201836
Oral solution for daily intake
Other Names:
  • Velmupressin
Drug: Placebo ODT
Manufactured to mimic experimental drug
Experimental: FE 201836 50 μg (Randomized Treatment Period)
FE 201836 50 μg oral solution and placebo ODT, administered once daily
Drug: FE 201836
Oral solution for daily intake
Other Names:
  • Velmupressin
Drug: Placebo ODT
Manufactured to mimic experimental drug
Experimental: Placebo (Randomized Treatment Period)
Placebo oral solution and placebo ODT, administered once daily
Drug: Placebo ODT
Manufactured to mimic experimental drug
Drug: Placebo oral solution
Manufactured to mimic experimental drug
Experimental: Desmopressin 25 μg (Randomized Treatment Period)
Desmopressin 25 μg ODT and placebo oral solution, administered once daily (female subjects)
Drug: Placebo oral solution
Manufactured to mimic experimental drug
Drug: Desmopressin
Desmopressin Orally Disintegrating Tablet (ODT)
Other Names:
  • NOCDURNA
Experimental: Desmopressin 50 μg (Randomized Treatment Period)
Desmopressin 50 μg ODT and placebo oral solution, administered once daily (male subjects)
Drug: Placebo oral solution
Manufactured to mimic experimental drug
Drug: Desmopressin
Desmopressin Orally Disintegrating Tablet (ODT)
Other Names:
  • NOCDURNA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Aggregated Mean Number of Nocturnal Voids During 12 Weeks of Treatment
Time Frame: Baseline, during 12 weeks of treatment

Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning.

The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. The visit-specific means were aggregated into a mean of current and preceding visits.

Level estimated for baseline value of mean number of nocturnal voids equal to 2, and 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval are presented in this endpoint.
Baseline, during 12 weeks of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Number of Nocturnal Voids at Week 1
Time Frame: Baseline, Week 1

Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning.

The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in nocturnal voids are estimated using a baseline value of 2.

MMRM=Mixed Model for Repeated Measurements.

For all visit-specific results, the tables present the number of subjects with an observation of the endpoints in question at the specific visit. All secondary analyses are performed using the observed-case approach based on repeated measurements for all subjects in the ITT-RT population. That is, these secondary analyses are based on all subjects with at least one non-missing post-baseline observation (with a baseline value if relevant).
Baseline, Week 1
Change From Baseline in Mean Number of Nocturnal Voids at Week 4
Time Frame: Baseline, Week 4

Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning.

The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in nocturnal voids are estimated using a baseline value of 2.
Baseline, Week 4
Change From Baseline in Mean Number of Nocturnal Voids at Week 8
Time Frame: Baseline, Week 8

Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning.

The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in nocturnal voids are estimated using a baseline value of 2.
Baseline, Week 8
Change From Baseline in Mean Number of Nocturnal Voids at Week 12
Time Frame: Baseline, Week 12

Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning.

The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in nocturnal voids are estimated using a baseline value of 2.
Baseline, Week 12
Responder Rate in Nocturnal Voids at Week 1
Time Frame: Week 1

Defined as 50% reduction in nocturnal voids from baseline.

Adjusted visit-specific estimated odds of at least 50% in the reduction mean number of nocturnal voids are estimated using a baseline value of 2.

The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).
Week 1
Responder Rate in Nocturnal Voids at Week 4
Time Frame: Week 4

Defined as 50% reduction in nocturnal voids from baseline.

Adjusted visit-specific estimated odds of at least 50% reduction in the mean number of nocturnal voids are estimated using a baseline value of 2.

The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).
Week 4
Responder Rate in Nocturnal Voids at Week 8
Time Frame: Week 8

Defined as 50% reduction in nocturnal voids from baseline.

Adjusted visit-specific estimated odds of at least 50% reduction in the mean number of nocturnal voids are estimated using a baseline value of 2.

The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).
Week 8
Responder Rate in Nocturnal Voids at Week 12
Time Frame: Week 12

Defined as 50% reduction in nocturnal voids from baseline.

Adjusted visit-specific estimated odds of at least 50% reduction in the mean number of nocturnal voids are estimated using a baseline value of 2.

The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).
Week 12
Responder Rate in Nocturnal Voids During 12 Weeks of Treatment
Time Frame: During 12 weeks of treatment

Defined as 50% reduction in nocturnal voids from baseline.

Estimated odds of at least 50% reduction in the aggregated mean number of nocturnal voids for a subject with 2 nocturnal voids at baseline are presented in this endpoint.

The 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval is presented for this endpoint.

The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).
During 12 weeks of treatment
Change From Baseline in Mean NI Diary Total Score at Week 1
Time Frame: Baseline, Week 1

The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall quality of life (QoL) impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items.Responses are scored from 0 to 4 (lowest t o highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact).

The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Total Score are estimated using a baseline value of 40.
Baseline, Week 1
Change From Baseline in Mean NI Diary Total Score at Week 4
Time Frame: Baseline, Week 4

The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items. Responses are scored from 0 to 4 (lowest to highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact).

The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Total Score are estimated using a baseline value of 40.
Baseline, Week 4
Change From Baseline in Mean NI Diary Total Score at Week 8
Time Frame: Baseline, Week 8

The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items. Responses are scored from 0 to 4 (lowest to highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact).

The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Total Score are estimated using a baseline value of 40.
Baseline, Week 8
Change From Baseline in Mean NI Diary Total Score at Week 12
Time Frame: Baseline, Week 12

The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items. Responses are scored from 0 to 4 (lowest to highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact).

The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Total Score are estimated using a baseline value of 40.
Baseline, Week 12
Change From Baseline in Aggregated Mean NI Diary Total Score During 12 Weeks of Treatment
Time Frame: Baseline, during 12 weeks of treatment

The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items. Responses are scored from 0 to 4 (lowest to highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact).

The score at each visit was calculated as the mean over the three consecutive 24 hour periods just prior to the respective visit. The visit-specific means were aggregated into a mean of current and preceding visits.

Level estimated for baseline value of mean NI Diary Total Score equal to 40 is presented in this endpoint.

The 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval is presented for this endpoint.
Baseline, during 12 weeks of treatment
Percentage of Nights With at Most One Nocturnal Void During 12 Weeks of Treatment
Time Frame: During 12 weeks of treatment

The percentages of nights during the treatment period with at most one nocturnal void are presented in this endpoint.

Level estimated for baseline value of mean number of nocturnal voids equal to 2 is presented in this endpoint.
During 12 weeks of treatment
Percentage of Nights With No Nocturnal Voids During 12 Weeks of Treatment
Time Frame: During 12 weeks of treatment

The percentages of nights during the treatment period with complete response, i.e. no nocturnal voids are presented in this endpoint.

Level estimated for baseline value of mean number of nocturnal voids equal to 2 is presented in this endpoint.
During 12 weeks of treatment
Change From Baseline in Mean NI Diary Overall Impact Score at Week 1
Time Frame: Baseline, Week 1

The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact).

The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Overall Impact Score are estimated using a baseline value of 40.
Baseline, Week 1
Change From Baseline in Mean NI Diary Overall Impact Score at Week 4
Time Frame: Baseline, Week 4

The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact).

The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Overall Impact Score are estimated using a baseline value of 40.
Baseline, Week 4
Change From Baseline in Mean NI Diary Overall Impact Score at Week 8
Time Frame: Baseline, Week 8

The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact).

The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Overall Impact Score are estimated using a baseline value of 40.
Baseline, Week 8
Change From Baseline in Mean NI Diary Overall Impact Score at Week 12
Time Frame: Baseline, Week 12

The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact).

The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Overall Impact Score are estimated using a baseline value of 40.
Baseline, Week 12
Change From Baseline in Aggregated Mean NI Diary Overall Impact Score During 12 Weeks of Treatment
Time Frame: Baseline, during 12 weeks of treatment

The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact).

The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. The visit-specific means were aggregated into a mean of current and preceding visits.

Level estimated for baseline value of mean NI Diary Overall Impact Score equal to 40 is presented in this endpoint.

The 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval is presented for this endpoint.
Baseline, during 12 weeks of treatment
Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 1
Time Frame: Week 1

The PGI-I is a 1-item questionnaire designed to assess the patient's impression of changes in urinary symptoms. The PGI-I was scored from 1 (very much better) to 7 (very much worse).

Visit-specific PGI-I in urinary symptoms is presented in this endpoint.
Week 1
Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 4
Time Frame: Week 4

The PGI-I is a 1-item questionnaire designed to assess the patient's impression of changes in urinary symptoms. The PGI-I was scored from 1 (very much better) to 7 (very much worse).

Visit-specific PGI-I in urinary symptoms is presented in this endpoint.
Week 4
Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 8
Time Frame: Week 8

The PGI-I is a 1-item questionnaire designed to assess the patient's impression of changes in urinary symptoms. The PGI-I was scored from 1 (very much better) to 7 (very much worse).

Visit-specific PGI-I in urinary symptoms is presented in this endpoint.
Week 8
Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 12
Time Frame: Week 12

The PGI-I is a 1-item questionnaire designed to assess the patient's impression of changes in urinary symptoms. The PGI-I was scored from 1 (very much better) to 7 (very much worse).

Visit-specific PGI-I in urinary symptoms is presented in this endpoint.
Week 12
Change From Baseline in Patient Global Impression of Severity (PGI-S) Scores at Week 1
Time Frame: Baseline, Week 1

The PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S was scored from 1 (none) to 4 (severe).

Change from baseline in visit-specific PGI-S is presented in this endpoint.

Level estimated for baseline value of PGI-S equal to 3 is presented in this endpoint.
Baseline, Week 1
Change From Baseline in PGI-S Scores at Week 4
Time Frame: Baseline, Week 4

The PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S was scored from 1 (none) to 4 (severe).

Change from baseline in visit-specific PGI-S is presented in this endpoint.

Level estimated for baseline value of PGI-S equal to 3 is presented in this endpoint.
Baseline, Week 4
Change From Baseline in PGI-S Scores at Week 8
Time Frame: Baseline, Week 8

The PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S was scored from 1 (none) to 4 (severe).

Change from baseline in visit-specific PGI-S is presented in this endpoint.

Level estimated for baseline value of PGI-S equal to 3 is presented in this endpoint.
Baseline, Week 8
Change From Baseline in PGI-S Scores at Week 12
Time Frame: Baseline, Week 12

The PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S was scored from 1 (none) to 4 (severe).

Change from baseline in visit-specific PGI-S is presented in this endpoint.

Level estimated for baseline value of PGI-S equal to 3 is presented in this endpoint.
Baseline, Week 12
Change From Baseline in Hsu 5-point Likert Bother Scale at Week 1
Time Frame: Baseline, Week 1

The Hsu 5-point Likert Bother scale is a questionnaire designed to assess the subjective bothersomeness and functional disruptiveness of nocturia. The Hsu 5 point Likert Bother Scale was scored from 0 (not at all) to 4 (extremely).

Change from baseline in visit-specific Hsu Bother is presented in this endpoint.

Level estimated for baseline value of Hsu Bother equal to 3 is presented in this endpoint.
Baseline, Week 1
Change From Baseline in Hsu 5-point Likert Bother Scale at Week 4
Time Frame: Baseline, Week 4

The Hsu 5-point Likert Bother scale is a questionnaire designed to assess the subjective bothersomeness and functional disruptiveness of nocturia. The Hsu 5 point Likert Bother Scale was scored from 0 (not at all) to 4 (extremely).

Change from baseline in visit-specific Hsu Bother is presented in this endpoint.

Level estimated for baseline value of Hsu Bother equal to 3 is presented in this endpoint.
Baseline, Week 4
Change From Baseline in Hsu 5-point Likert Bother Scale at Week 8
Time Frame: Baseline, Week 8

The Hsu 5-point Likert Bother scale is a questionnaire designed to assess the subjective bothersomeness and functional disruptiveness of nocturia. The Hsu 5 point Likert Bother Scale was scored from 0 (not at all) to 4 (extremely).

Change from baseline in visit-specific Hsu Bother is presented in this endpoint.

Level estimated for baseline value of Hsu Bother equal to 3 is presented in this endpoint.
Baseline, Week 8
Change From Baseline in Hsu 5-point Likert Bother Scale at Week 12
Time Frame: Baseline, Week 12

The Hsu 5-point Likert Bother scale is a questionnaire designed to assess the subjective bothersomeness and functional disruptiveness of nocturia. The Hsu 5 point Likert Bother Scale was scored from 0 (not at all) to 4 (extremely).

Change from baseline in visit-specific Hsu Bother is presented in this endpoint.

Level estimated for baseline value of Hsu Bother equal to 3 is presented in this endpoint.
Baseline, Week 12
Change From Baseline in ISI at Week 4
Time Frame: Baseline, Week 4

The ISI is a 7-item questionnaire which comprises of four 'sleep-related' items and three 'wake-related' items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28 (higher score suggests more severe insomnia).

Change from baseline in visit-specific ISI is presented in this endpoint.

Level estimated for baseline value of ISI equal to 15 is presented in this endpoint.
Baseline, Week 4
Change From Baseline in ISI at Week 8
Time Frame: Baseline, Week 8

The ISI is a 7-item questionnaire which comprises of four 'sleep-related' items and three 'wake-related' items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28 (higher score suggests more severe insomnia).

Change from baseline in visit-specific ISI is presented in this endpoint.

Level estimated for baseline value of ISI equal to 15 is presented in this endpoint.
Baseline, Week 8
Change From Baseline in ISI at Week 12
Time Frame: Baseline, Week 12

The ISI is a 7-item questionnaire which comprises of four 'sleep-related' items and three 'wake-related' items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28 (higher score suggests more severe insomnia).

Change from baseline in visit-specific ISI is presented in this endpoint.

Level estimated for baseline value of ISI equal to 15 is presented in this endpoint.
Baseline, Week 12
Change From Baseline in Mean Duration of First Undisturbed Sleep Period (FUSP) at Week 1
Time Frame: Baseline, Week 1

The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occured.

The duration of FUSP at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in FUSP are estimated using a baseline value of 180 (min).
Baseline, Week 1
Change From Baseline in Mean Duration of FUSP at Week 4
Time Frame: Baseline, Week 4

The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occurred.

The duration of FUSP at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in FUSP are estimated using a baseline value of 180 (min).
Baseline, Week 4
Change From Baseline in Mean Duration of FUSP at Week 8
Time Frame: Baseline, Week 8

The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occurred.

The duration of FUSP at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in FUSP are estimated using a baseline value of 180 (min).
Baseline, Week 8
Change From Baseline in Mean Duration of FUSP at Week 12
Time Frame: Baseline, Week 12

The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occurred.

The duration of FUSP at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in FUSP are estimated using a baseline value of 180 (min).
Baseline, Week 12
Change From Baseline in Aggregated Mean Duration of FUSP During 12 Weeks of Treatment
Time Frame: Baseline, During 12 Weeks of Treatment

The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occurred.

The visit-specific means were aggregated into a mean of current and preceding visits.

Level estimated for baseline value of mean duration of FUSP (minutes) equal to 180 is presented in this endpoint.

The 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval is presented for this endpoint.
Baseline, During 12 Weeks of Treatment
Change From Baseline in Nocturnal Diuresis Rate Profiles at Week 1
Time Frame: Baseline, Week 1

The nocturnal diuresis rate (mL/min) is calculated as the mean of the nocturnal diuresis for each of the three nights, with the single-night nocturnal diuresis calculated as the ratio of NUV to total time in bed.

Change from baseline in visit-specific mean nocturnal diuresis (mL/min) is presented.

Level estimated for baseline value of mean nocturnal diuresis (mL/min) equal to 1.3 is presented in this endpoint.
Baseline, Week 1
Change From Baseline in Nocturnal Diuresis Rate Profiles at Week 12
Time Frame: Baseline, Week 12

The nocturnal diuresis rate (mL/min) is calculated as the mean of the nocturnal diuresis for each of the three nights, with the single-night nocturnal diuresis calculated as the ratio of NUV to total time in bed.

Change from baseline in visit-specific mean nocturnal diuresis (mL/min) is presented.

Level estimated for baseline value of mean nocturnal diuresis (mL/min) equal to 1.3 is presented in this endpoint.
Baseline, Week 12
Change From Baseline in Mean NUV in Week 1
Time Frame: Baseline, Week 1

The NUV is defined as the total urine volume from 5 minutes after bedtime with the intention to sleep including the first void within 30 minutes of rising in the morning.

The NUV at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NUV are estimated using a baseline value of 750 (mL).
Baseline, Week 1
Change From Baseline in Mean NUV at Week 12
Time Frame: Baseline, Week 12

The NUV is defined as the total urine volume from 5 minutes after bedtime with the intention to sleep including the first void within 30 minutes of rising in the morning.

The NUV at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NUV are estimated using a baseline value of 750 (mL).
Baseline, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ferring Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 27, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 000233
  • 2016-003851-31 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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