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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 is a Phase 3 study that has completed, run by NICHD Pelvic Floor Disorders Network. The registered enrollment target is 300 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02008565
The ClinicalTrials.gov registry entry for NCT02008565 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NICHD Pelvic Floor Disorders Network, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02008565 reports 0 study locations.
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.
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