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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.

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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

FieldValue
Enrollment Target 300 participants
Start Date 2014-02
Est. Completion 2016-05
Phase Phase 3

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.