At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 34 enrolled
Drug / intervention
RBX2660 (microbiota suspension)biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Open-label Clinical Trial Demonstrating the Safety of RBX2660 Microbiota Suspension for the Treatment of Recurrent Clostridium Difficile-associated Diarrhea (CDAD): the PUNCH CD Study
In Brief
A Phase 2 clinical trial evaluating RBX2660 (microbiota suspension) for Recurrent Clostridium Difficile Infection. Completed, enrolled 34 participants across 13 sites.
Detailed Summary
This study will assess the safety of a new biologic drug, RBX2660 (microbiota suspension) as a treatment for recurrent Clostridium difficile-associated diarrhea (CDAD), which is the primary symptom of recurrent Clostridium difficile infection. All eligible subjects will receive RBX2660.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartAug 2013
First PostedAug 2013
Primary CompletionMar 2014
Study CompletionJul 2014
TodayJul 2026
First PostedAug 19, 2013
Enrollment StartAug 1, 2013
Primary CompletionMar 1, 2014
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 12.9 years ago
Interventions
RBX2660 (microbiota suspension)biological