Treatment of Chlamydia Infection Comparing WC2031 Tablets With Vibramycin

Phase 3

Completed

• Conditions: Urogential Chlamydia Trachomatis Infection
• Interventions: Drug: Doxycyline Hyclate tablet; Drug: Vibramycin (doxycyline hyclate) capsule

• Registration Number: NCT01113931
• Lead Sponsor: Warner Chilcott

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-28
• Study First Submitted QC: 2010-04-29
• Study First Posted: 2010-04-30
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Results First Submitted: 2011-11-09
• Status Verified: 2011-12
• Results First Submitted QC: 2011-12-21
• Last Update Submitted: 2011-12-21
• Results First Posted: 2012-01-27
• Last Update Posted: 2012-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 495

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Doxycycline Hyclate 200 mg tablet	Doxycyline Hyclate tablet	Once daily
Vibramycin 100 mg capsule	Vibramycin (doxycyline hyclate) capsule	Twice daily

Primary Outcome Measures

Name	Time	Method
Microbiological Cure Rate	Day 28	Percentage of Subjects in mITT Population with Microbiological Cure defined as a negative result for C. trachomatis as determined by GP AC2 NAAT (Gen-Probe Aptima Combo 2 Nucleic Acid Amplification Test) at Day 28

Secondary Outcome Measures

Name	Time	Method
Microbiological Cure and Clinical Cure of C. Trachomatis, Day 28, Clinically Evaluable Population, Percentage Participants Cured	End of Study (Day 28)	Microbiological cure (defined as a negative result for urogenital C. trachomatis, determined by GP AC2 NAAT/Gen-Probe Aptima Combo 2 Nucleic Acid Amplification Test and clinical cure (for males defined as resolution of baseline signs/symptoms of dysuria, urethral pruritus and urethral discharge, and resolution of exam finding of urethral discharge; for females resolution of exam finding of endocervical discharge) at Day 28
Microbiological Cure C. Trachomatis and M. Genitalium, M. Genitalium Coinfected Population, Day 28, Percentage Participants Cured	End of Study (Day 28)	Percentage Subjects Cured of both M. genitalium and C. trachomatis M. genitalium co-infected population: microbiological cure for both at Day 28, defined as negative PCR (polymerase chain reaction) for M. genitalium and negative GP AC2 NAAT (Gen-Probe Aptima Combo 2 Nucleic Acid Amplification test) for C. trachomatis at Day 28
Microbiological Cure C. Trachomatis, N. Gonorrhoea Negative Population, Day 28, Percentage Participants Cured	Day 28	Percentage Participants cured in N. gonorrhoea Negative Population: cured defined as both microbiological cure (negative result for urogenital C. trachomatis, determined by GP AC2 NAAT/Gen-Probe Aptima Combo 2 Nucleic Acid Amplification test) and clinical cure (males defined as resolution of baseline signs/symptoms of dysuria, urethral pruritis and urethral discharge, and resolution of exam finding of urethral discharge; females - resolution of exam finding of endocervical discharge) at Day 28

Trial Locations

Locations (1)

Research Site; 🇺🇸 Tacoma, Washington, United States