NCT03201419|CompletedPhase 2ResultsDMCFDA Drug

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

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

Ferring Pharmaceuticals ClinicalTrials.gov

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2 other identifiers

0002332016-003851-31

Study Type

interventional

Target

302

Locations

7 countries

Sites

Timeline

RegisteredJun 2017

StartedJul 2017

CompletionOct 2019

Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

302

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jul 2017

Geographic Reach

7 countries

72 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.3 years study duration

First Submitted

Initial submission to the registry

June 26, 2017

Completed

2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2017

Completed

29 days until next milestone

Study Start

First participant enrolled

July 27, 2017

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

December 23, 2020

Completed

Last Updated

March 2, 2022

Status Verified

October 1, 2020

Enrollment Period

2.3 years

First QC Date

June 26, 2017

Results QC Date

October 28, 2020

Last Update Submit

February 17, 2022

Conditions

Nocturia

Outcome Measures

Primary Outcomes (1)

Change From Baseline in Aggregated Mean Number of Nocturnal Voids 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 Outcomes (45)

Change From Baseline in Mean Number of Nocturnal Voids at Week 1
Baseline, Week 1
Change From Baseline in Mean Number of Nocturnal Voids at Week 4
Baseline, Week 4
Change From Baseline in Mean Number of Nocturnal Voids at Week 8
Baseline, Week 8
Change From Baseline in Mean Number of Nocturnal Voids at Week 12
Baseline, Week 12
Responder Rate in Nocturnal Voids at Week 1
Week 1
+40 more secondary outcomes

Study Arms (9)

FE 201836 500 μg (Randomized Treatment Period)

EXPERIMENTAL

FE 201836 500 μg oral solution and placebo orally disintegrating tablet (ODT), administered once daily