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NCT01259726 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of VP20621 for Prevention of Recurrent Clostridium Difficile Infection
A Phase 2 study, sponsored by Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 173
- Enrollment target
NCT01259726 is a Phase 2 study that has completed, run by Shire. The registered enrollment target is 173 participants.
The verdict
NCT01259726, a Phase 2 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 173 participants
- Enrollment target
Study Summary
The objectives of this study are: (1) to evaluate the safety and tolerability of VP 20621 dosed orally for up to 14 days in adults previously treated for CDI; (2) to characterize the frequency and duration of stool colonization with the VP 20621 strain of C. difficile; (3) to evaluate the efficacy of VP 20621 for prevention of recurrence of CDI; and (4)to select a dose regimen of VP 20621 to be used in future studies.
Interventions
- OTHER Placebo
- BIOLOGICAL VP20621
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 173 participants |
| Start Date | 2011-06-27 |
| Est. Completion | 2013-06-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01259726
The ClinicalTrials.gov registry entry for NCT01259726 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 173 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01259726 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01259726 about?
NCT01259726 is a clinical study titled "Safety and Efficacy Study of VP20621 for Prevention of Recurrent Clostridium Difficile Infection". The objectives of this study are: (1) to evaluate the safety and tolerability of VP 20621 dosed orally for up to 14 days in adults previously treated for CDI; (2) to characterize the frequency and duration of stool colonization with the VP 20621 strain of C. difficile; (3) to evaluate the efficacy o...
What is the current status of trial NCT01259726?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 173 participants. The study started on 2011-06-27. Estimated completion is 2013-06-11.
What interventions are being tested in trial NCT01259726?
The interventions under investigation include: Placebo (OTHER), VP20621 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01259726?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
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