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NCT01552343 · ClinicalTrials.gov registry record · Phase 3
Study Investigating the Impact Burden of Nocturia Using the Nocturia Impact Diary
A Phase 3 study of Nocturia, sponsored by Ferring Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 56
- Enrollment target
- 10
- Study locations
NCT01552343: Completed Phase 3 study of Nocturia, sponsored by Ferring Pharmaceuticals.
NCT01552343 is a Phase 3 study of Nocturia that has completed, run by Ferring Pharmaceuticals. The registered enrollment target is 56 participants, below the 310-participant average among 9 other Nocturia trials with a reported enrollment target (82% lower). The trial reports 10 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01552343, a Phase 3 study of Nocturia, has completed, sponsored by Ferring Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 56 participants
- Enrollment target
- 10
- Study locations
Study Summary
The purpose of this study is to assess psychometric properties (reliability and validity) of the Nocturia Impact (NI) diary. To assess the association between reduction of number of nocturnal voids and the mean changes in NI scores (sensitivity of the NI total score to change in nocturia). To assess which NI diary items account for the main difference in change in total NI score in treatment versus placebo.
Primary Outcome
This outcome is a measure of sensitivity of the NI Diary to change in nocturia. The NI Diary is a 12-item instrument consisting of 11 core items and an overall impact question (Q12). Responses are scored from 0 (no impact) to 4 (highest impact); a lowering of score equals a decrease in impact caused by nocturia. The NI total score is the sum of the 11 core items scores. The NI total score was analyzable only if all 11 items (Q1-Q11) had non-missing responses. Otherwise, it was defined as missin
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Desmopressin
Study Locations (10)
Florida
- South Florida Medical Research - Aventura
- Avail Clinical Research, LLC - DeLand
Michigan
- Beyer Research - Kalamazoo
- Remedica LLC - Rochester
Texas
- Quality Research, Inc. - San Antonio
- Radiant Research, Inc. - San Antonio
Illinois
- Accelovance - Peoria
Massachusetts
- DM Clinical Research - Springfield
New York
- Accumed Research Associates - Garden City
South Carolina
- Radiant Research, Inc. - Greer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2012-03 |
| Est. Completion | 2012-06 |
| Phase | Phase 3 |
What the finished NCT01552343 record still lists
NCT01552343 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 310-participant average among 9 other Nocturia trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Nocturia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01552343 lists 10 locations in 7 states (Florida, Michigan, Texas).
Frequently Asked Questions
What is clinical trial NCT01552343 about?
NCT01552343 is a clinical study titled "Study Investigating the Impact Burden of Nocturia Using the Nocturia Impact Diary". The purpose of this study is to assess psychometric properties (reliability and validity) of the Nocturia Impact (NI) diary. To assess the association between reduction of number of nocturnal voids and the mean changes in NI scores (sensitivity of the NI total score to change in nocturia). To asse...
What is the current status of trial NCT01552343?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 56 participants. The study started on 2012-03. Estimated completion is 2012-06.
What conditions does trial NCT01552343 study?
This clinical trial studies the following conditions: Nocturia.
What interventions are being tested in trial NCT01552343?
The interventions under investigation include: Placebo (DRUG), Desmopressin (DRUG).
Who is sponsoring clinical trial NCT01552343?
This trial is sponsored by Ferring Pharmaceuticals, which has 83 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01552343 being conducted?
This trial has 10 study locations across Florida, Illinois, Massachusetts, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01552343's enrollment target sits among peer trials
56 9th of 9 higher than 1 of 9 other Nocturia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Nocturia 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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