Trial Investigating the Long Term Safety and Tolerability of Desmopressin Orally Disintegrating Tablets (ODT) for Nocturia Due to Nocturnal Polyuria in Japanese Subjects

NCT03051009 | Completed Phase 3

• 1 other identifier: 000131
• Study Type: interventional
• Target: 503
• Locations: 1 country
• Sites: 1

Brief Summary

Demonstrate the safety and tolerability of desmopressin ODT during long-term treatment of subjects with nocturia due to nocturnal polyuria, for up to 1 year

Conditions

Nocturia

Outcome Measures

Primary Outcomes (3)

• The frequency and severity of adverse events

  During long-term treatment

  Up to 1 year

• Clinically significant changes in laboratory values and vital signs

  During long-term treatment

  Up to 1 year

• The incidence and severity of hyponatraemia

  Measured by serum sodium levels during long-term treatment

  Up to 1 year

Secondary Outcomes (7)

• Change from baseline in mean number of nocturnal voids

  Week 12, 24, 40 and 52

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

  Week 12, 24, 40 and 52

• Change from baseline in mean nocturnal urin volume

  Week 12, 24, 40 and 52

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

  Week 12, 24, 40 and 52

• Change from baseline in Nocturia-Specific Quality-of-Life Questionnaire (N-QoL)

  Week 12, 24, 40 and 52

Study Arms (8)

Desmopressin ODT 25 μg (female previous on 25 μg)

EXPERIMENTAL

Subjects received 25 μg in trial 000129.

Drug: Desmopressin ODT 25 μg

Desmopressin ODT 25 μg (female previously on placebo)

EXPERIMENTAL

Subjects received placebo in trial 000129

Drug: Desmopressin ODT 25 μg

Desmopressin ODT 25 μg (female)

EXPERIMENTAL

New female subjects

Drug: Desmopressin ODT 25 μg

Desmopressin ODT 25 μg (male previous on 25 μg)

EXPERIMENTAL

Subjects received 25 μg in trial 000130

Drug: Desmopressin ODT 25 μg

Desmopressin ODT 50 μg (male previous on 50 μg)

EXPERIMENTAL

Subjects received 50 μg in trial 000130

Drug: Desmopressin ODT 50 μg

Desmopressin ODT 50 μg (male previous on placebo)

EXPERIMENTAL

Subjects received placebo in trial 000130

Drug: Desmopressin ODT 50 μg

Desmopressin ODT 25 μg (male)

EXPERIMENTAL

Subjects received placebo in trial 000130

Drug: Desmopressin ODT 25 μg

Desmopressin ODT 50 μg (male)

EXPERIMENTAL

New male subjects

Drug: Desmopressin ODT 50 μg

Interventions

Desmopressin ODT 25 μg DRUG

Also known as: FE 992026

Desmopressin ODT 25 μg (female previous on 25 μg); Desmopressin ODT 25 μg (female previously on placebo); Desmopressin ODT 25 μg (female); Desmopressin ODT 25 μg (male previous on 25 μg); Desmopressin ODT 25 μg (male)

Desmopressin ODT 50 μg DRUG

Also known as: FE 992026

Desmopressin ODT 50 μg (male previous on 50 μg); Desmopressin ODT 50 μg (male previous on placebo); Desmopressin ODT 50 μg (male)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• 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 for the 000131 trial
• Has completed participation in trial 000129 or 000130

You may not qualify if:

• Hyponatraemia (serum sodium level \<135 mmol/L) at Visit 7 in trial 000129 or 000130
• Withdrawal from clinical trial 000129 or 000130
• Written informed consent prior to performance of any trial-related activity
• Adult ≥20 years of age
• Nocturia symptoms present for ≥6 months prior to trial entry at Visit 1a
• Nocturnal polyuria at the end of screening period prior to Visit 1b
• Bothered by nocturia on the Hsu 5-point Likert bother scale at Visit 1a and Visit 1b
• Has given agreement about contraception during the trial
• Early withdrawal from clinical trial 000129 or 000130
• Evidence of any significant voiding dysfunction resulting in abnormally low bladder capacity at the end of the screening period prior to Visit 1b
• History or evidence of significant obstructive sleep apnoea
• History or diagnosis of any of the following urological diseases:
• Interstitial cystitis or bladder pain disorder
• In males, 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (1)

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

Tokyo, Japan

Location

MeSH Terms

Conditions

Nocturia

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: One dose level (25 μg desmopressin OCD) is included for female subjects and will be open-labelled for all female subjects. Two different dose levels (25 μg desmopressin and 50 μg desmopressin ODT are included for male subjects in a double-blinded manner. Male subjects continuing from trial 000130 will continue their randomised treatment and subjects who received placebo will be randomised to one of the 2 dose levels (25 μg desmopressin or 50 μg desmopressin ODT). New male subjects will be allocated to receive 50 μg desmopressin ODT in an open-labelled manner.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The trial is designed as partly an extension trial for subjects completing trial 000129 (female subjects) and 000130 (male subjects) and partly as a trial for new female and male subjects.

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 13, 2017
• Study Start: January 11, 2017
• Primary Completion: September 11, 2018
• Study Completion: September 11, 2018
• Last Updated: September 17, 2018

Record last verified: 2018-09

Locations

JP (1)