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NCT01262456 · ClinicalTrials.gov registry record · Phase 3
Investigation of the Superiority Effect of Orally Disintegrating Desmopressin Tablets to Placebo in Terms of Night Voids Reduction in Nocturia Adult Male Patients
A Phase 3 study, sponsored by Ferring Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 395
- Enrollment target
NCT01262456: Completed Phase 3 study, sponsored by Ferring Pharmaceuticals.
NCT01262456 is a Phase 3 study that has completed, run by Ferring Pharmaceuticals. The registered enrollment target is 395 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01262456, a Phase 3 study, has completed, sponsored by Ferring Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 395 participants
- Enrollment target
Study Summary
The purpose of this trial was to confirm/establish long-term safety and efficacy of desmopressin orally disintegrating tablets at dose levels of 50 μg and 75 μg and to further evaluate the safety of an efficacious higher dose level of 100 μg in males with nocturia.
Primary Outcome
The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during-treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void. Change from baseline values for Week 1, and Months 1, 2 and 3 are reported below. Comparison of the mean number of nocturnal voids at baseline and over a 3-month treatment period (obtained by longitudinal analysis of Week 1, and Months 1, 2
Interventions
- DRUG Placebo
- DRUG Desmopressin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 395 participants |
| Start Date | 2011-02 |
| Est. Completion | 2012-01 |
| Phase | Phase 3 |
What the finished NCT01262456 record still lists
NCT01262456 is an interventional study that assigns participants to a tested intervention. The registered 395 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01262456 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01262456 about?
NCT01262456 is a clinical study titled "Investigation of the Superiority Effect of Orally Disintegrating Desmopressin Tablets to Placebo in Terms of Night Voids Reduction in Nocturia Adult Male Patients". The purpose of this trial was to confirm/establish long-term safety and efficacy of desmopressin orally disintegrating tablets at dose levels of 50 μg and 75 μg and to further evaluate the safety of an efficacious higher dose level of 100 μg in males with nocturia.
What is the current status of trial NCT01262456?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 395 participants. The study started on 2011-02. Estimated completion is 2012-01.
What interventions are being tested in trial NCT01262456?
The interventions under investigation include: Placebo (DRUG), Desmopressin (DRUG).
Who is sponsoring clinical trial NCT01262456?
This trial is sponsored by Ferring Pharmaceuticals, which has 83 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01262456's enrollment target sits among peer trials
395 965th of 2000 higher than 1,034 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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