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NCT02240121 · ClinicalTrials.gov registry record · Phase 3
One Year Study of Rifaximin Delayed Release (DR) Tablets in Crohn's Disease
A Phase 3 study, sponsored by Bausch Health Americas.
- Terminated
- Registry status
- Phase 3
- Development phase
- 80
- Enrollment target
NCT02240121 is a Phase 3 study that was terminated before completion, run by Bausch Health Americas. The registered enrollment target is 80 participants.
The verdict
NCT02240121, a Phase 3 study, was terminated before completion, sponsored by Bausch Health Americas.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 80 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.
Interventions
- DRUG Placebo
- DRUG Rifaximin EIR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2014-08-21 |
| Est. Completion | 2017-08-16 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02240121
The ClinicalTrials.gov registry entry for NCT02240121 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch Health Americas, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02240121 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02240121 about?
NCT02240121 is a clinical study titled "One Year Study of Rifaximin Delayed Release (DR) Tablets 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 NCT02240121?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 80 participants. The study started on 2014-08-21. Estimated completion is 2017-08-16.
What interventions are being tested in trial NCT02240121?
The interventions under investigation include: Placebo (DRUG), Rifaximin EIR (DRUG).
Who is sponsoring clinical trial NCT02240121?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
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