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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 is a Phase 3 study that has completed, run by Rebiotix. The registered enrollment target is 320 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03244644
The ClinicalTrials.gov registry entry for NCT03244644 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rebiotix, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03244644 reports 0 study locations.
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.
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