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NCT01631201 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of Rifalazil for the Treatment of Chlamydia Trachomatis Infection in Women
A Phase 2 study of Chlamydia Trachomatis Infection, sponsored by ActivBiotics Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 82
- Enrollment target
- 5
- Study locations
NCT01631201: Completed Phase 2 study of Chlamydia Trachomatis Infection, sponsored by ActivBiotics Pharma.
NCT01631201 is a Phase 2 study of Chlamydia Trachomatis Infection that has completed, run by ActivBiotics Pharma. The registered enrollment target is 82 participants, below the 1,173-participant average among 3 other Chlamydia Trachomatis Infection trials with a reported enrollment target (93% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01631201, a Phase 2 study of Chlamydia Trachomatis Infection, has completed, sponsored by ActivBiotics Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 82 participants
- Enrollment target
- 5
- Study locations
Study Summary
This study will test the safety and effectiveness of an investigational antibiotic drug, rifalazil for the treatment of uncomplicated genital Chlamydia trachomatis infection. This study will examine the effects of 25 milligram of rifalazil compared with azithromycin 1 gram, which will be given as a single dose to women who have genital chlamydial infection.
Primary Outcome
Microbiologic test result will be reported as positive or negative for chlamydia trachomatis.
Conditions Studied
Interventions
- DRUG Rifalazil 25 milligram
- DRUG Azithromycin 1 gram
Study Locations (5)
Alabama
- Research Site - Birmingham
California
- Research Site - San Diego
Indiana
- Research Site - Indianapolis
Nevada
- Research Site - Las Vegas
Virginia
- Research Site - Virginia Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2012-07 |
| Est. Completion | 2013-04 |
| Phase | Phase 2 |
What the finished NCT01631201 record still lists
NCT01631201 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 1,173-participant average among 3 other Chlamydia Trachomatis Infection trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Chlamydia Trachomatis Infection appearing as the primary indexed condition, and to 2 interventions - of which Rifalazil 25 milligram is the first listed.
NCT01631201 lists 5 locations in 5 states (Alabama, California, Indiana).
Frequently Asked Questions
What is clinical trial NCT01631201 about?
NCT01631201 is a clinical study titled "Safety and Efficacy Study of Rifalazil for the Treatment of Chlamydia Trachomatis Infection in Women". This study will test the safety and effectiveness of an investigational antibiotic drug, rifalazil for the treatment of uncomplicated genital Chlamydia trachomatis infection. This study will examine the effects of 25 milligram of rifalazil compared with azithromycin 1 gram, which will be given as a ...
What is the current status of trial NCT01631201?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 2012-07. Estimated completion is 2013-04.
What conditions does trial NCT01631201 study?
This clinical trial studies the following conditions: Chlamydia Trachomatis Infection.
What interventions are being tested in trial NCT01631201?
The interventions under investigation include: Rifalazil 25 milligram (DRUG), Azithromycin 1 gram (DRUG).
Who is sponsoring clinical trial NCT01631201?
This trial is sponsored by ActivBiotics Pharma, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01631201 being conducted?
This trial has 5 study locations across Alabama, California, Indiana, Nevada, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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