Trial of Desmopressin Orally Disintegrating Tablets (ODT) for Nocturia Due to Nocturnal Polyuria in Japanese Male Subjects

A Randomised, Double-blind, Placebo-controlled, Multi-centre Trial Investigating the Efficacy and Safety of Desmopressin (FE 992026) Orally Disintegrating Tablets During 12 Weeks of Treatment for Nocturia Due to Nocturnal Polyuria in Japanese Male Subjects

The purpose of this trial is to demonstrate efficacy of desmopressin ODT against placebo for the treatment of male subjects with nocturia due to nocturnal polyuria, during 12 weeks of treatment.

Study Overview

• Status: Completed
• Conditions: Nocturia
• Intervention / Treatment: Drug: Placebo; Drug: Desmopressin

• Study Type: Interventional
• Enrollment (Actual): 342
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Investigational site (there may be other sites in this country)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Written informed consent prior to performance of any trial-related activity
• Man ≥20 years of age
• Nocturia symptoms present for ≥6 months prior to trial entry at Visit 1
• ≥2 nocturnal voids at the end of screening period prior to Visit 2
• Nocturnal polyuria at the end of screening period prior to Visit 2
• Bothered by nocturia on the Hsu 5-point Likert bother scale at Visit 1 and Visit 2
• Has given agreement about contraception during the trial

Exclusion Criteria:

• Evidence of any significant voiding dysfunction resulting in abnormally low bladder capacity at the end of the screening period prior to Visit 2
• History or evidence of significant obstructive sleep apnoea

• History or diagnosis of any of the following urological diseases at Visit 1:

  • Interstitial cystitis or bladder pain disorder

  • Suspicion of moderate or severe benign prostate hyperplasia (BPH), defined as international prostate symptom score (IPSS) ≥8 points and:

    • Urinary flow <5 mL/s or
    • Post-void residual volume >150 mL
  • Stress urinary incontinence or mixed incontinence, where stress incontinence is the predominant component based on prior history
  • Chronic pelvic pain syndrome
• Surgical treatment, including transurethral resection, for bladder outlet obstruction (BOO) or BPH within the past 6 months prior to Visit 1

• Symptoms of severe over-active bladder (OAB):

  • Defined as an over-active bladder symptom score (OABSS) ≥12 at Visit 1
  • Defined as a mean of >8 voids and a mean of ≥1 urgency episode per 24 hours at the end of the screening period prior to Visit 2
• Genito-urinary tract pathology that can in the investigator's opinion be responsible for urgency or urinary incontinence at Visit 1
• Complication of cancer or a history of cancer which has not been in remission for the last 5 years at Visit 1
• Current or a history of urologic malignancies, any lower urinary tract surgery, previous pelvic irradiation, or neoplasia at Visit 1
• History of any neurological disease affecting bladder function or muscle strength at Visit 1
• Habitual or psychogenic polydipsia based on medical history at Visit 1 or 24 hour urine output of >2.8 L based on the voiding diary at Visit 2
• Central or nephrogenic diabetes insipidus at Visit 1
• Syndrome of inappropriate antidiuretic hormone secretion at Visit 1
• Suspicion or evidence of cardiac failure at Visit 1
• Uncontrolled hypertension at Visit 1
• Uncontrolled diabetes mellitus at Visit 1
• Hyponatraemia (serum sodium level <135 mmol/L) at Visit 1
• Renal insufficiency at Visit 1
• Hepatic and/or biliary diseases at Visit 1
• Known or suspected hypersensitivity to desmopressin ODTs or previous desmopressin treatment for nocturia at Visit 1
• Known alcohol or substance abuse at Visit 1
• Work or lifestyle that may interfere with regular night-time sleep at Visit 1, e.g., shift workers
• Any other medical condition, laboratory abnormality, psychiatric condition, mental incapacity, or language barrier that, in the judgment of the investigator, would impair participation in the trial at Visit 1
• Use of any prohibited therapy during the trial period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo ODT	Drug: Placebo
Experimental: Desmopressin 25 µg; Desmopressin ODT	Drug: Desmopressin; Other Names: FE 992026
Experimental: Desmopressin 50 µg; Desmopressin ODT	Drug: Desmopressin; Other Names: FE 992026

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in mean number of nocturnal voids during 12 weeks of treatment	Assessed by the 3-day voiding diary	Week 1, 4, 8 and 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in mean time to first awakening to void	Assessed by the 3-day voiding diary	Week 1, 4, 8 and 12
Change from baseline in mean nocturnal urine volume	Assessed by the 3-day voiding diary	Week 1, 4, 8 and 12
Change from baseline in mean Nocturnal Polyuria Index (NPI)	Assessed by the 3-day voiding diary	Week 1, 4, 8 and 12
Change from baseline in Nocturia-Specific Quality-of-Life Questionnaire (N-QoL)		Week 8 and 12
Change from baseline in Insomnia Severity Index (ISI)		Week 8 and 12
Change from baseline in bother score	Assessed by the Hsu 5-point Likert bother scale	Week 8 and 12
Frequency and severity of adverse events		From screening to week 12

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Publications and helpful links

General Publications

• Yamaguchi O, Juul KV, Falahati A, Yoshimura T, Imura F, Kitamura M. Efficacy and safety of 25 and 50 mug desmopressin orally disintegrating tablets in Japanese patients with nocturia due to nocturnal polyuria: Results from two phase 3 studies of a multicenter randomized double-blind placebo-controlled parallel-group development program. Low Urin Tract Symptoms. 2020 Jan;12(1):8-19. doi: 10.1111/luts.12276. Epub 2019 Aug 9.

Helpful Links

• Article

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): September 29, 2017
• Study Completion (Actual): September 29, 2017

Study Registration Dates

• First Submitted: September 14, 2016
• First Submitted That Met QC Criteria: September 16, 2016
• First Posted (Estimate): September 19, 2016

Study Record Updates

• Last Update Posted (Actual): September 11, 2019
• Last Update Submitted That Met QC Criteria: September 9, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Nocturia; Polyuria; Physiological Effects of Drugs; Natriuretic Agents; Hemostatics; Coagulants; Antidiuretic Agents; Deamino Arginine Vasopressin
• Other Study ID Numbers: 000130