Treatment of Chlamydia Infection Comparing WC2031 Tablets With Vibramycin

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Warner Chilcott
• Treatments: Doxycycline

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