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NCT03244644 · ClinicalTrials.gov registry record · Phase 3
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)
A Phase 3 study, sponsored by Rebiotix.
- Completed
- Registry status
- Phase 3
- Development phase
- 320
- Enrollment target
NCT03244644: Completed Phase 3 study, sponsored by Rebiotix.
NCT03244644 is a Phase 3 study that has completed, run by Rebiotix. The registered enrollment target is 320 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03244644, a Phase 3 study, has completed, sponsored by Rebiotix.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 320 participants
- Enrollment target
Study Summary
This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy or have had at least two episodes of severe Clostridioides difficile infection (CDI) resulting in hospitalization within the last year may be eligible for the study. Subjects who are deemed failures following the blinded treatment per the pre-specified treatment failure definition may elect to receive an unblinded dose of RBX2660.
Primary Outcome
The primary efficacy endpoint was the absence of CDI diarrhea for 8 weeks after study treatment. The model-estimated rate of treatment success, that is the model-estimated percentage of participants that met the primary efficacy endpoint, was estimated using a Bayesian hierarchical model, which formally incorporated data from a previous randomized Phase 2B study (NCT02299570) of RBX2660.
Interventions
- DRUG Placebo
- DRUG RBX2660
- DRUG Open label RBX2660 (only for confirmed CDI recurrence)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2017-07-31 |
| Est. Completion | 2020-08-03 |
| Phase | Phase 3 |
What the finished NCT03244644 record still lists
NCT03244644 is an interventional study that assigns participants to a tested intervention. The registered 320 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 (59% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03244644 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03244644 about?
NCT03244644 is a clinical study titled "Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)". This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy ...
What is the current status of trial NCT03244644?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 320 participants. The study started on 2017-07-31. Estimated completion is 2020-08-03.
What interventions are being tested in trial NCT03244644?
The interventions under investigation include: Placebo (DRUG), RBX2660 (DRUG), Open label RBX2660 (only for confirmed CDI recurrence) (DRUG).
Who is sponsoring clinical trial NCT03244644?
This trial is sponsored by Rebiotix, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03244644's enrollment target sits among peer trials
320 1082nd of 2000 higher than 914 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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