Urogential Chlamydia Trachomatis Infection Clinical Trial
Official title:
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
| Verified date | December 2011 |
| Source | Warner Chilcott |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 495 |
| Est. completion date | October 2010 |
| Est. primary completion date | October 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 19 Years to 45 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site | Anaheim | California |
| United States | Research Site | Arkansas City | Kansas |
| United States | Research Site | Birmingham | Alabama |
| United States | Research Site | Boca Raton | Florida |
| United States | Research Site | Boynton Beach | Florida |
| United States | Research Site | Brooklyn | New York |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Columbus | Ohio |
| United States | Research Site | Decatur | Georgia |
| United States | Research Site | Detroit | Michigan |
| United States | Research Site | Fall River | Massachusetts |
| United States | Research Site | Foley | Alabama |
| United States | Research Site | Fresno | California |
| United States | Research Site | Greensboro | North Carolina |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Indianapolis | Indiana |
| United States | Research Site | Jackson | Mississippi |
| United States | Research Site | Jefferson Hills | Pennsylvania |
| United States | Research Site | Jenkintown | Pennsylvania |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Margate | Florida |
| United States | Research Site | Marrero | Louisiana |
| United States | Research Site | Myrtle Beach | South Carolina |
| United States | Research Site | New Bern | North Carolina |
| United States | Research Site | New Orleans | Louisiana |
| United States | Research Site | New Orleans | Louisiana |
| United States | Research Site | Newton | Kansas |
| United States | Research Site | Norfolk | Virginia |
| United States | Research Site | North Las Vegas | Nevada |
| United States | Research Site | North Miami | Florida |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Raleigh | North Carolina |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Diego | California |
| United States | Research Site | Savannah | Georgia |
| United States | Research Site | South Miami | Florida |
| United States | Research Site | Spokane | Washington |
| United States | Research Site | Tacoma | Washington |
| United States | Research Site | Tucson | Arizona |
| United States | Research Site | West Palm Beach | Florida |
| United States | Research Site | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Warner Chilcott |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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) | No |
| Secondary | 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) | No |
| Secondary | 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 | No |