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NCT02376972 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety Study of Rifaximin Vaginal Tablets in Bacterial Vaginosis
A Phase 2 study, sponsored by Alfasigma S.p.A..
- Terminated
- Registry status
- Phase 2
- Development phase
- 392
- Enrollment target
NCT02376972: Clinical Trial Phase 2 study, sponsored by Alfasigma S.p.A..
NCT02376972 is a Phase 2 study that was terminated before completion, run by Alfasigma S.p.A.. The registered enrollment target is 392 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (195% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02376972, a Phase 2 study, was terminated before completion, sponsored by Alfasigma S.p.A..
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 392 participants
- Enrollment target
Study Summary
THE STUDY HAS BEEN DESIGNED TO COMPARE THE EFFICACY OF TWO DOSES (25 MG AND 100 MG) OF RIFAXIMIN VAGINAL TABLETS VERSUS PLACEBO IN SUBJECTS WITH BACTERIAL VAGINOSIS
Primary Outcome
RESOLUTION OF 3 OUT OF 4 AMSEL'S CRITERIA, I.E. NORMAL PHYSIOLOGICAL DISCHARGE, NEGATIVE "WHIFF TEST", CLUE CELLS \>20%
Interventions
- DRUG RIFAXIMIN VAGINAL TABLET 25 MG
- DRUG RIFAXIMIN VAGINAL TABLET 100 MG
- DRUG PLACEBO VAGINAL TABLET
- DRUG METROGEL VAGINAL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 392 participants |
| Start Date | 2015-04 |
| Est. Completion | 2016-02 |
| Phase | Phase 2 |
Why NCT02376972 stopped before completion
NCT02376972 is an interventional study that assigns participants to a tested intervention. The registered 392 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (195% higher).
The record links to 0 conditions, and to 4 interventions - of which RIFAXIMIN VAGINAL TABLET 25 MG is the first listed.
NCT02376972 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02376972 about?
NCT02376972 is a clinical study titled "Efficacy and Safety Study of Rifaximin Vaginal Tablets in Bacterial Vaginosis". THE STUDY HAS BEEN DESIGNED TO COMPARE THE EFFICACY OF TWO DOSES (25 MG AND 100 MG) OF RIFAXIMIN VAGINAL TABLETS VERSUS PLACEBO IN SUBJECTS WITH BACTERIAL VAGINOSIS
What is the current status of trial NCT02376972?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 392 participants. The study started on 2015-04. Estimated completion is 2016-02.
What interventions are being tested in trial NCT02376972?
The interventions under investigation include: RIFAXIMIN VAGINAL TABLET 25 MG (DRUG), RIFAXIMIN VAGINAL TABLET 100 MG (DRUG), PLACEBO VAGINAL TABLET (DRUG), METROGEL VAGINAL (DRUG).
Who is sponsoring clinical trial NCT02376972?
This trial is sponsored by Alfasigma S.p.A., which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02376972's enrollment target sits among peer trials
392 105th of 2000 higher than 1,895 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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