Trials / Completed
CompletedNCT01078753
Study With Two Different Doses of Desmopressin Orally Lyophilisate Tablet With Nocturnal Enuresis
A Double-blind, Placebo-controlled, Phase III Comparative Study With FE992026 in Children and Adolescents With Reduced Night-time Urinary Osmolarity-type Nocturnal Enuresis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 89 (actual)
- Sponsor
- Ferring Pharmaceuticals · Industry
- Sex
- All
- Age
- 6 Years – 15 Years
- Healthy volunteers
- Not accepted
Summary
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."
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Desmopressin | Desmopressin oral lyophilisate tablet, 120 μg or 240 μg, administered sublingually once a day 1½ hours before bedtime. |
| DRUG | Placebo | Placebo oral lyophilisate tablet was administered sublingually once a day 1½ hours before bedtime. |
Timeline
- Start date
- 2010-01-01
- Primary completion
- 2010-09-01
- Completion
- 2010-09-01
- First posted
- 2010-03-02
- Last updated
- 2011-11-02
- Results posted
- 2011-11-02
Locations
15 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT01078753. Inclusion in this directory is not an endorsement.