Treatment of Chlamydia Infection Comparing WC2031 Tablets With Vibramycin

Warner Chilcott

Status and phase: Completed; Phase 3

Conditions: Urogential Chlamydia Trachomatis Infection

Treatments: Drug: Vibramycin (doxycyline hyclate) capsule; Drug: Doxycyline Hyclate tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT01113931

PR-04809

Details and patient eligibility

About

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.

Enrollment: 495 patients

Sex: All

Ages: 19 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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495 participants in 2 patient groups

Doxycycline Hyclate 200 mg tablet

Experimental group

Description:

Once daily

Treatment:

Drug: Doxycyline Hyclate tablet

Vibramycin 100 mg capsule

Active Comparator group

Description:

Twice daily

Treatment:

Drug: Vibramycin (doxycyline hyclate) capsule