Treatment of Chlamydia Infection Comparing WC2031 Tablets With Vibramycin

Completed · Phase 3

Conditions studied: Urogential Chlamydia Trachomatis Infection

In brief

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.

Key facts

Study ID

NCT01113931

Run by

Warner Chilcott

People needed

495

Starts

2010-04-01

Expected to finish

2010-10-01

Last updated by the study team

2012-01-27

Who can join

Age: 19 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Research Site — Birmingham, Alabama, United States
• Research Site — Foley, Alabama, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Anaheim, California, United States
• Research Site — Fresno, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — San Diego, California, United States
• Research Site — Boca Raton, Florida, United States
• Research Site — Boynton Beach, Florida, United States
• Research Site — Margate, Florida, United States
• Research Site — North Miami, Florida, United States
• Research Site — South Miami, Florida, United States
• Research Site — West Palm Beach, Florida, United States
• Research Site — Decatur, Georgia, United States
• Research Site — Savannah, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Arkansas City, Kansas, United States
• Research Site — Newton, Kansas, United States
• Research Site — Wichita, Kansas, United States
• Research Site — Marrero, Louisiana, United States
• Research Site — New Orleans, Louisiana, United States
• Research Site — New Orleans, Louisiana, United States
• Research Site — Fall River, Massachusetts, United States
• Research Site — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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