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

NCT02904759 | Completed Phase 3

• 1 other identifier: 000130
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nocturia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change from baseline in mean time to first awakening to void

  Week 1, 4, 8 and 12

• Change from baseline in mean nocturnal urine volume

  Week 1, 4, 8 and 12

• Change from baseline in mean Nocturnal Polyuria Index (NPI)

  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

Study Arms (3)

Desmopressin 25 µg

EXPERIMENTAL

Desmopressin ODT

Drug: Desmopressin

Desmopressin 50 µg

EXPERIMENTAL

Desmopressin ODT

Drug: Desmopressin

Placebo

PLACEBO COMPARATOR

Placebo ODT

Drug: Placebo

Interventions

Desmopressin DRUG

Also known as: FE 992026

Desmopressin 25 µg; Desmopressin 50 µg

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (1)

Investigational site (there may be other sites in this country)

Tokyo, Japan

Location

Related Publications (1)

• 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.

  PMID: 31397969 RESULT

MeSH Terms

Conditions

Nocturia

Interventions

Deamino Arginine Vasopressin

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 19, 2016
• Study Start: September 1, 2016
• Primary Completion: September 29, 2017
• Study Completion: September 29, 2017
• Last Updated: September 11, 2019

Record last verified: 2019-09

Locations

JP (1)