Comparative Trial to Investigate the Efficacy and Safety of Desmopressin for the Treatment of Nocturia in Adult Men (NOC)

August 22, 2013 updated by: Ferring Pharmaceuticals

A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Trial Investigating the Efficacy and Safety of Two Different Dose Levels of Desmopressin for the Treatment of Nocturia in Adult Men

The purpose of the study is to investigate the efficacy and safety of two different dose levels of desmopressin orally disintegrating tablets against placebo for the treatment of nocturia in adult men during 12 weeks treatment

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.
183

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

  • Japan
      • Chiba, Japan
        • Clinic Tsudanuma
      • Fukui, Japan
        • University of Fukui Hospital
      • Gunma, Japan
        • Kato Clinic
      • Gunma, Japan
        • Umeyama Clinic
      • Hyogo, Japan
        • Harada Urology Clinic
      • Hyogo, Japan
        • Sakaguchi Urological Clinic
      • Kanagawa, Japan
        • Nakamura Urology Clinic
      • Kanagawa, Japan
        • Nishi-Yokohama International Hospital
      • Kanagawa, Japan
        • Yokohama Shinmidori General Hospital
      • Kochi, Japan
        • Izumino Hospital, Bouchikai
      • Kochi, Japan
        • Kamei Clinic
      • Osaka, Japan
        • Den Urology Clinic
      • Osaka, Japan
        • Iwasa Clinic
      • Osaka, Japan
        • Kanno Clinic
      • Osaka, Japan
        • Morimoto Clinic
      • Osaka, Japan
        • Naka Clinic
      • Osaka, Japan
        • Uemura Clinic
      • Osaka, Japan
        • Urology department Kuroda Clinic
      • Osaka, Japan
        • Yamaguchi Clinic
      • Osaka, Japan
        • Yamanaka Clinic
      • Saitama, Japan
        • Fukuda Clinic
      • Saitama, Japan
        • Yasuda Urology Clinic
      • Tokyo, Japan
        • Hirano Clinic
      • Tokyo, Japan
        • Hirata Internal Medicine Urology Clinic
      • Tokyo, Japan
        • J Tower Clinic
      • Tokyo, Japan
        • Koganeibashi Sakura Clinic
      • Tokyo, Japan
        • Kunitachi Sakura Hospital
      • Tokyo, Japan
        • Kusunoki Clinic
      • Tokyo, Japan
        • Moriguchi Clinic
      • Tokyo, Japan
        • Nakanoma Clinic Urology Department
      • Tokyo, Japan
        • Ogawa Clinic
      • Tokyo, Japan
        • Ogikubo Ekimae Clinic
      • Tokyo, Japan
        • Shibuya Shin-minamiguchi Clinic
      • Tokyo, Japan
        • Tokyo Kamata Hospital
      • Tokyo, Japan
        • Toru Clinic

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Has given written consent prior to any trial-related activity is performed
  • Male sex, aged 20 years or older
  • At least 2 nocturnal voids every night in a consecutive 3-day period as documented in the diary during the screening period
  • Has given agreement about contraception during the trial

Exclusion Criteria:

  • Suspicion of bladder outlet obstruction or a urine flow of less than 5 mL/s as confirmed by uroflowmetry after suspicion of bladder outlet obstruction
  • A surgical treatment for bladder outlet obstruction or prostatic hyperplasia within the past 6 months
  • Showing symptoms of any of the following diseases: Benign prostatic obstruction; Interstitial cystitis; Overactive bladder, defined as >6 daytime voids, ≥1 urgency episode, and ≥1 urge urinary incontinence episode per 24 hours as documented in the 3-day diary period; Severe stress urinary incontinence
  • Chronic prostatitis/chronic pelvic pain syndrome
  • Psychogenic or habitual polydipsia
  • Urinary retention or a post void residual volume in excess of 150 mL as confirmed by bladder ultrasound performed after suspicion of urinary retention
  • Cancer
  • A history of urologic malignancies or a history of cancer which has not been in remission for the last 5 years
  • Genito-urinary tract pathology
  • Neurogenic detrusor activity
  • Suspicion or evidence of heart failure
  • Uncontrolled hypertension
  • Uncontrolled diabetes mellitus
  • Hepatobiliary diseases: Aspartate aminotransferase >80 U/L or alanine aminotransferase >90 U/L; Total bilirubin >1.5 mg/dL
  • Renal insufficiency: Serum creatinine level >1.09 mg/dL; Estimated glomerular filtration rate <50 mL/min
  • Hyponatraemia: Serum sodium level <135 mEq/L
  • Central or nephrogenic diabetes insipidus
  • Syndrome of inappropriate antidiuretic hormone
  • Obstructive sleep apnea
  • Previous desmopressin treatment
  • Treatment with another investigational product within the past 3 months
  • Concomitant treatment with any prohibited medication
  • Alcohol or substance abuse
  • A job or lifestyle that may interfere with regular night-time sleep
  • A mental condition, lack of decision-making ability, dementia, a speech handicap, or any other reason which, in the judgement of the investigator (sub-investigator), would impair the participation in the trial

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.
Active Comparator: A. Desmopressin 25 µg
1 orally disintegrating tablet every night during study period
Drug: A: Desmopressin 25 µg
Active Comparator: B. Desmopressin 50 µg
1 orally disintegrating tablet every night during study period
Drug: B. Desmopressin 50 µg
Placebo Comparator: C. Placebo
1 orally disintegrating tablet every night during study period
Drug: Placebo

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
Time Frame
Change from baseline in mean number of nocturnal voids
Time Frame: During 12 weeks
During 12 weeks

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
Time Frame
Change from baseline in mean time to first void
Time Frame: During 12 weeks
During 12 weeks
Responder status (33% reduction in nocturnal voids)
Time Frame: During 12 weeks
During 12 weeks
Change from baseline in mean number of nocturnal voids
Time Frame: 1, 4, 8 and 12 weeks
1, 4, 8 and 12 weeks
Change from baseline in mean time to first void
Time Frame: 1, 4, 8 and 12 weeks
1, 4, 8 and 12 weeks
Responder status (33% reduction in nocturnal voids)
Time Frame: 1, 4, 8 and 12 weeks
1, 4, 8 and 12 weeks
Change from baseline in mean nocturnal urine volume
Time Frame: 1, 4, 8 and 12 weeks
1, 4, 8 and 12 weeks
Change from baseline in nocturnal polyuria index
Time Frame: 1, 4, 8 and 12 weeks
1, 4, 8 and 12 weeks
Change from baseline in the effect on sleep disturbance
Time Frame: 1, 4, 8 and 12 weeks
1, 4, 8 and 12 weeks
Change from baseline in the impact on quality of life
Time Frame: 12 weeks
12 weeks
Adverse events, changes from baseline in serum sodium level, laboratory values
Time Frame: During 12 weeks
During 12 weeks

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

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

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.
September 1, 2012

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.
June 1, 2013

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.
June 1, 2013

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).
September 11, 2012

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.
September 25, 2012

First Posted (Estimate)

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.
September 27, 2012

Study Record Updates

Last Update Posted (Estimate)

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.
August 23, 2013

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.
August 22, 2013

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.
August 1, 2013

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.
  • 000030

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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