NCT00615836

A Multi-Center Extension Study Investigating the Long Term Efficacy and Safety of a Fast-Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults

Completed Phase 3 Results posted Last updated 11 November 2015

What this trial tests

Phase 3 trial testing Desmopressin Melt in Nocturia in 554 participants. Completed in 1 May 2010.

Timeline

1 December 2007

Primary endpoint
1 May 2010

1 May 2010

Quick facts

Lead sponsor	Ferring Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	554
Start date	1 December 2007
Primary completion	1 May 2010
Estimated completion	1 May 2010
Sites	73 locations across United States, Canada

Drugs / interventions tested

• Desmopressin Melt

Conditions studied

• Nocturia — all drugs for Nocturia →

Sponsor

Ferring Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Nocturia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change From Baseline in Mean Number of Nocturnal Voids
  Time frame: Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.
  Participants completed a voiding diary for 3 consecutive 24-hour periods prior to the study visit in which they recorded each nocturnal urination (void). The mean number of voids per night was the average number of voids from the 3-day diary. Baseline refers to Baseline of Study CS29 and the number of weeks represents the total exposure to study drug. Participants in the 10μg arm are included onl
• Percentage of Participants With a Greater Than 33% Reduction in the Mean Number of Nocturnal Voids
  Time frame: Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.
  Percentage of participants with \>33% reduction from Baseline in the mean number of nocturnal urinations per night, calculated from the 3-day voiding diary completed prior to each study visit. Participants in the 10μg arm are included only until the time of dose escalation.
• Change From Baseline in Initial Period of Undisturbed Sleep
  Time frame: Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.
  Participants completed a sleep diary on 3 consecutive mornings prior to each study visit, from which the initial period of undisturbed sleep was calculated and averaged for the 3 days. The Initial Period of Undisturbed Sleep is the time elapsed from bedtime to either first void or morning arising minus the minutes it took to fall asleep. Baseline refers to Baseline of Study CS29 and the number of

Sponsor's own description

The purpose of this study was to investigate the long term efficacy and safety of several doses of the Melt formulation of desmopressin in a broad population of adult patients with nocturia.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pharmacologic management of nocturnal polyuria: a contemporary assessment of efficacy, safety, and progress toward individualized treatment.
   Monaghan TF, Weiss JP, Everaert K, Wein AJ. · · 2021 · cited 6× · PMID 33796148 · DOI 10.1177/1756287220988438