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NCT02008565 · ClinicalTrials.gov registry record · Phase 3
Controlling Anal Incontinence by Performing Anal Exercises With Biofeedback or Loperamide (CAPABLe)
A Phase 3 study, sponsored by NICHD Pelvic Floor Disorders Network.
- Completed
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
NCT02008565: Completed Phase 3 study, sponsored by NICHD Pelvic Floor Disorders Network.
NCT02008565 is a Phase 3 study that has completed, run by NICHD Pelvic Floor Disorders Network. The registered enrollment target is 300 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02008565, a Phase 3 study, has completed, sponsored by NICHD Pelvic Floor Disorders Network.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
Study Summary
The study is a multi-center, randomized, placebo controlled trial with participants randomized into one of four groups: 1. placebo/usual care (educational pamphlet) 2. loperamide/usual care (educational pamphlet) 3. placebo/anal exercises with biofeedback 4. loperamide/anal exercises with biofeedback The primary outcome, change from baseline in St. Marks (Vaizey) Score at 24 weeks, will be compared between treatment groups using linear regression.
Primary Outcome
The primary outcome measure for all study arms is the change from baseline in St. Mark's (Vaizey) Score 24 weeks after treatment initiation to compare the marginal outcomes of anal exercise with biofeedback to usual care and loperamide to placebo. The St. Mark's (Vaizey) score, published in 1999, is commonly used in clinical studies and reports and was based on the Jorge-Wexner score but added two further items for assessment: the use of constipating medication and the presence of fecal urgency
Interventions
- DRUG Placebo
- BEHAVIORAL Usual Care
- DRUG Loperamide
- BEHAVIORAL Anal exercises with biofeedback
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2014-02 |
| Est. Completion | 2016-05 |
| Phase | Phase 3 |
What the finished NCT02008565 record still lists
NCT02008565 is an interventional study that assigns participants to a tested intervention. The registered 300 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 (61% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02008565 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02008565 about?
NCT02008565 is a clinical study titled "Controlling Anal Incontinence by Performing Anal Exercises With Biofeedback or Loperamide (CAPABLe)". The study is a multi-center, randomized, placebo controlled trial with participants randomized into one of four groups: 1. placebo/usual care (educational pamphlet) 2. loperamide/usual care (educational pamphlet) 3. placebo/anal exercises with biofeedback 4. loperamide/anal exercises with biofeedba...
What is the current status of trial NCT02008565?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2014-02. Estimated completion is 2016-05.
What interventions are being tested in trial NCT02008565?
The interventions under investigation include: Placebo (DRUG), Usual Care (BEHAVIORAL), Loperamide (DRUG), Anal exercises with biofeedback (BEHAVIORAL).
Who is sponsoring clinical trial NCT02008565?
This trial is sponsored by NICHD Pelvic Floor Disorders Network, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02008565's enrollment target sits among peer trials
300 1122nd of 2000 higher than 840 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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