Phase 3
N=799
An Extension Study Investigating the Efficacy and Safety of a Fast-Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults
Nocturia
Bottom Line
View on ClinicalTrials.gov: NCT00615836 ↗Enrolled (actual)
799
Serious AEs
8.0%
Results posted
Dec 2015
Primary outcome: Primary: Change From Baseline in Mean Number of Nocturnal Voids — -1.12; -1.30; -1.42; -1.47 nocturnal voids
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Desmopressin Melt (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ferring Pharmaceuticals
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Number of Nocturnal Voids |
-1.12; -1.30; -1.42; -1.47; -1.15; -1.40 | — |
| PRIMARY Percentage of Participants With a Greater Than 33% Reduction in the Mean Number of Nocturnal Voids |
57.3; 63.5; 67.4; 68.3; 60.0; 67.9 | — |
| PRIMARY Change From Baseline in Initial Period of Undisturbed Sleep |
77.64; 96.58; 104.72; 126.63; 97.57; 116.70 | — |
| SECONDARY Change From Baseline in Total Sleep Time |
13.93; 19.77; 33.17; 14.68; 20.66; 24.94 | — |
| SECONDARY Change From Baseline in International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) Nighttime Urination Bother Score |
-3.68; -2.62; -3.77; -3.71; NA; -2.83 | — |
| SECONDARY Change From Baseline in Nocturia Quality of Life (NQoL) Overall Score |
20.16; 22.42; 22.06; 26.13; NA; 19.37 | — |
| SECONDARY Change From Baseline in NQoL Bother/Concern Domain Score |
22.43; 22.82; 23.30; 28.81; NA; 18.27 | — |
| SECONDARY Change From Baseline in Nocturia Quality of Life (NQoL) Sleep/Energy Domain Score |
17.89; 22.02; 20.83; 23.45; NA; 20.20 | — |
| SECONDARY Change From Baseline in the Nocturia Quality of Life (NQoL) Global Quality of Life Score |
0.29; 0.36; 0.68; 0.26; NA; 0.38 | — |
| SECONDARY Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Global Score |
-2.41; -2.59; -3.52; -2.94; NA; -1.59 | — |
| SECONDARY Change From Baseline in the Short Form-12, Version 2 (SF-12v2) Mental Component Summary Score |
5.82; 3.84; 1.57; 4.14; NA; 0.53 | — |
| SECONDARY Change From Baseline in the Short Form-12, Version 2 (SF-12v2) Physical Component Summary Score |
1.23; 1.42; 2.62; 0.14; NA; 1.35 | — |
| SECONDARY Participants With Treatment-Emergent Adverse Events (AEs) |
81; 149; 188; 187; 190; 0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Written informed consent prior to the performance of any study-related activity.
- Was randomized into Part II of Protocol FE992026 CS29 (NCT00477490), entitled "A Randomized, Double Blind,Placebo Controlled, Parallel Group, Multi-Center Study with a Double Blind Extension Investigating the Efficacy and Safety of a Fast-Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults" and have completed at least Visit 3E in Part II (Day 15).
Exclusion Criteria
- Patients using loop diuretics (furosemide, torsemide, ethacrynic acid).
Data sourced from ClinicalTrials.gov (NCT00615836). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.