NCT01113931

Treatment of Chlamydia Infection Comparing WC2031 Tablets With Vibramycin

Safety and Efficacy of WC2031 Versus Vibramycin for the Treatment of Uncomplicated Urogenital Chlamydia Trachomatis Infection: A Randomized, Double-blind, Double-dummy, Active-controlled, Multicenter Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 495 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urogential Chlamydia Trachomatis Infection

Interventions

Type	Name	Description
DRUG	Doxycyline Hyclate tablet	200 mg tablet, once daily for 7 days
DRUG	Vibramycin (doxycyline hyclate) capsule	100 mg capsule, twice daily for 7 days, over-encapsulated

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2010-04-30
• Last updated: 2012-01-27
• Results posted: 2012-01-27

Locations

43 sites across 1 country: United States