Clinical trial
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection…
NCT03244644 · Rebiotix Inc., Industry · Completed
Key facts
| NCT number | NCT03244644 |
|---|---|
| Title | Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3) |
| Official title | A Phase 3 Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of RBX2660 (Microbiota Suspension) for the Prevention of Clostridium Difficile Infection |
| Lead sponsor | Rebiotix Inc., Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Clostridium Difficile Infection (CDI) |
| Intervention type | Drug |
| Interventions | RBX2660, Placebo, Open label RBX2660 (only for confirmed CDI recurrence) |
| Enrollment | 320 |
| Start date | Jul 31, 2017 |
| Primary completion | Apr 2, 2020 |
| Completion | Aug 3, 2020 |
| First posted | Aug 9, 2017 |
| Last update posted | Jul 10, 2024 |
| Countries | Canada, United States |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: