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A Double-blind, Placebo-controlled, Phase III Comparative Study With FE992026 in Children and Adolescents With Reduced Night-time Urinary Osmolarity-type Nocturnal Enuresis (PNE)
This is multi-center, randomized, placebo-controlled, parallel-group, double-blind, dose-escalating clinical trial designed to assess the efficacy and safety of desmopressin orally lyophilisate for the treatment of nocturnal enuresis "with decreased nighttime urinary osmolality."
Details
| Lead sponsor | Ferring Pharmaceuticals |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 89 |
| Start date | 2010-01 |
| Completion | 2010-09 |
Conditions
- Nocturnal Enuresis
Interventions
- Desmopressin
- Placebo
Primary outcomes
- Change in the Number of Wet Nights Between Baseline and Treatment Period II — Baseline (14-day period prior to starting study treatment) and Treatment Period II (weeks 3-4 after treatment initiation).
The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Baseline Period minus the number of wet nights during the 14-day Treatment Period II.
Countries
Japan