CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 495 enrolled
Drug / intervention
Doxycyline Hyclate tablet +1 moredrug
Likely dose
Doxycyline Hyclate tablet 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01113931
NCT01113931Phase 3Completed
CompareCT.gov

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

Warner Chilcott·interventional·Posted Apr 30, 2010·Updated Jan 27, 2012

In Brief

A Phase 3 clinical trial evaluating Doxycyline Hyclate tablet and Vibramycin (doxycyline hyclate) capsule for Urogential Chlamydia Trachomatis Infection. Completed, enrolled 495 participants across 43 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrogential Chlamydia Trachomatis Infection
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 30, 2010
Enrollment StartApr 1, 2010
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 16.2 years ago

Interventions

Doxycyline Hyclate tabletdrug

200 mg tablet, once daily for 7 days

Vibramycin (doxycyline hyclate) capsuledrug

100 mg capsule, twice daily for 7 days, over-encapsulated