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NCT02240108 · ClinicalTrials.gov registry record · Phase 3
One Year Study of Rifaximin Delayed Release (DR) in Crohn's Disease
A Phase 3 study, sponsored by Bausch Health Americas.
- Terminated
- Registry status
- Phase 3
- Development phase
- 81
- Enrollment target
NCT02240108: Clinical Trial Phase 3 study, sponsored by Bausch Health Americas.
NCT02240108 is a Phase 3 study that was terminated before completion, run by Bausch Health Americas. The registered enrollment target is 81 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02240108, a Phase 3 study, was terminated before completion, sponsored by Bausch Health Americas.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 81 participants
- Enrollment target
Study Summary
The primary objective is to determine the efficacy of rifaximin DR also referred to as Extended Intestinal Release (EIR) tablets vs. placebo for the induction of clinical remission and endoscopic response following 16 weeks of treatment in participants presenting with active moderate Crohn's disease. A key secondary objective is to evaluate clinical and endoscopic remission following an additional 36 weeks of treatment.
Primary Outcome
Clinical symptom remission defined by (1) the total number of liquid/very soft stools for the 7 days prior to the Week 16 visit being less than or equal to (≤) 10 (from CDAI Item 1). CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores
Interventions
- DRUG Placebo
- DRUG Rifaximin EIR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2014-10-28 |
| Est. Completion | 2017-10-06 |
| Phase | Phase 3 |
Why NCT02240108 stopped before completion
NCT02240108 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02240108 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02240108 about?
NCT02240108 is a clinical study titled "One Year Study of Rifaximin Delayed Release (DR) in Crohn's Disease". The primary objective is to determine the efficacy of rifaximin DR also referred to as Extended Intestinal Release (EIR) tablets vs. placebo for the induction of clinical remission and endoscopic response following 16 weeks of treatment in participants presenting with active moderate Crohn's disease...
What is the current status of trial NCT02240108?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 81 participants. The study started on 2014-10-28. Estimated completion is 2017-10-06.
What interventions are being tested in trial NCT02240108?
The interventions under investigation include: Placebo (DRUG), Rifaximin EIR (DRUG).
Who is sponsoring clinical trial NCT02240108?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02240108's enrollment target sits among peer trials
81 1752nd of 2000 higher than 246 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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