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NCT01113931 · ClinicalTrials.gov registry record · Phase 3
Treatment of Chlamydia Infection Comparing WC2031 Tablets With Vibramycin
A Phase 3 study, sponsored by Warner Chilcott.
- Completed
- Registry status
- Phase 3
- Development phase
- 495
- Enrollment target
NCT01113931: Completed Phase 3 study, sponsored by Warner Chilcott.
NCT01113931 is a Phase 3 study that has completed, run by Warner Chilcott. The registered enrollment target is 495 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01113931, a Phase 3 study, has completed, sponsored by Warner Chilcott.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 495 participants
- Enrollment target
Study Summary
Evaluate the clinical efficacy and safety of WC2031 200 mg tablets taken orally once a day for 7 days versus Vibramycin (doxycycline) 100 mg capsules taken orally twice a day for 7 days, for the treatment of uncomplicated urogenital Chlamydia trachomatis infection. Primary efficacy endpoint is microbiological cure at Day 28. Safety assessments are adverse events, changes in vital signs and laboratory test results.
Primary Outcome
Percentage of Subjects in mITT Population with Microbiological Cure defined as a negative result for C. trachomatis as determined by GP AC2 NAAT (Gen-Probe Aptima Combo 2 Nucleic Acid Amplification Test) at Day 28
Interventions
- DRUG Doxycyline Hyclate tablet
- DRUG Vibramycin (doxycyline hyclate) capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 495 participants |
| Start Date | 2010-04 |
| Est. Completion | 2010-10 |
| Phase | Phase 3 |
What the finished NCT01113931 record still lists
NCT01113931 is an interventional study that assigns participants to a tested intervention. The registered 495 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower).
The record links to 0 conditions, and to 2 interventions - of which Doxycyline Hyclate tablet is the first listed.
NCT01113931 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01113931 about?
NCT01113931 is a clinical study titled "Treatment of Chlamydia Infection Comparing WC2031 Tablets With Vibramycin". Evaluate the clinical efficacy and safety of WC2031 200 mg tablets taken orally once a day for 7 days versus Vibramycin (doxycycline) 100 mg capsules taken orally twice a day for 7 days, for the treatment of uncomplicated urogenital Chlamydia trachomatis infection. Primary efficacy endpoint is micro...
What is the current status of trial NCT01113931?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 495 participants. The study started on 2010-04. Estimated completion is 2010-10.
What interventions are being tested in trial NCT01113931?
The interventions under investigation include: Doxycyline Hyclate tablet (DRUG), Vibramycin (doxycyline hyclate) capsule (DRUG).
Who is sponsoring clinical trial NCT01113931?
This trial is sponsored by Warner Chilcott, which has 53 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01113931's enrollment target sits among peer trials
495 778th of 2000 higher than 1,222 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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