drugset / Trial / NCT01113931

Treatment of Chlamydia Infection Comparing WC2031 Tablets With Vibramycin

NCT01113931 ↗

Phase 3 Completed 495 enrolled Warner Chilcott
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2010-04
Primary completion
2010-10
Completion
2010-10

Outcome

Met primary endpoint

paper CONCLUSIONS: WC2031 was noninferior to Vibramycin for uncomplicated urogenital chlamydia treatment, better tolerated, and demonstrated comparable safety. PMID 22431798 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Doxycycline Small molecule 100 mg —
Subject Doxycycline Small molecule 200 mg —