Treatment of Chlamydia Infection Comparing WC2031 Tablets With Vibramycin

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Urogential Chlamydia Trachomatis Infection

Intervention / Treatment
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* Drug: Doxycyline Hyclate tablet
* Drug: Vibramycin (doxycyline hyclate) capsule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Doxycycline Hyclate 200 mg tablet<br>Once daily | Drug: Doxycyline Hyclate tablet<br>* 200 mg tablet, once daily for 7 days<br>* Other names: WC2031;|
| Active Comparator: Vibramycin 100 mg capsule<br>Twice daily | Drug: Vibramycin (doxycyline hyclate) capsule<br>* 100 mg capsule, twice daily for 7 days, over-encapsulated<br>* Other names: doxycycline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological Cure Rate | 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 | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological Cure and Clinical Cure of C. Trachomatis, Day 28, Clinically Evaluable Population, Percentage Participants Cured | 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 | End of Study (Day 28) | 
| Microbiological Cure C. Trachomatis and M. Genitalium, M. Genitalium Coinfected Population, Day 28, Percentage Participants Cured | 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 | End of Study (Day 28) | 
| Microbiological Cure C. Trachomatis, N. Gonorrhoea Negative Population, Day 28, Percentage Participants Cured | 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 | Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chlamydia