Phase 3
Completed N=495
Treatment of Chlamydia Infection Comparing WC2031 Tablets With Vibramycin
Urogential Chlamydia Trachomatis Infection
Source: ClinicalTrials.gov NCT01113931 ↗
Enrolled (actual)
495
Serious AEs
0.0%
Results posted
Jan 2012
Primary outcomePrimary: Microbiological Cure Rate — 94.9; 94.6 percentage of participants cured
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Microbiological Cure Rate |
94.9; 94.6 | — |
| SECONDARY Microbiological Cure and Clinical Cure of C. Trachomatis, Day 28, Clinically Evaluable Population, Percentage Participants Cured |
80.0; 68.6 | — |
| SECONDARY Microbiological Cure C. Trachomatis and M. Genitalium, M. Genitalium Coinfected Population, Day 28, Percentage Participants Cured |
38.5; 18.2 | — |
| SECONDARY Microbiological Cure C. Trachomatis, N. Gonorrhoea Negative Population, Day 28, Percentage Participants Cured |
94.9; 94.6 | — |
Eligibility Criteria
Inclusion Criteria
- 19-45 years of age, male or female
- presumed diagnosis of urogenital C. trachomatis infection
- use condoms during sexual activity during study (enrollment thru day 28)
Exclusion Criteria
- Clinical diagnosis pelvic inflammatory disease or epididymitis at baseline
- Diagnosis of N. gonorrhoea
- HIV infection
- Active Hepatitis B or C infection
- Prior hysterectomy (partial or total)
- Treatment with antimicrobial therapy with known activity against urogenital C. trachomatis within 28 days of enrollment
Data sourced from ClinicalTrials.gov (NCT01113931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.