Treatment of Chlamydia Infection Comparing WC2031 Tablets With Vibramycin

December 21, 2011 updated by: Warner Chilcott

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

495

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Research Site
      • Foley, Alabama, United States, 36535
        • Research Site
    • Arizona
      • Tucson, Arizona, United States, 85710
        • Research Site
    • California
      • Anaheim, California, United States, 92805
        • Research Site
      • Fresno, California, United States, 93726
        • Research Site
      • Los Angeles, California, United States, 90007
        • Research Site
      • San Diego, California, United States, 92108
        • Research Site
    • Florida
      • Boca Raton, Florida, United States, 33432
        • Research Site
      • Boynton Beach, Florida, United States, 33472
        • Research Site
      • Margate, Florida, United States, 33063
        • Research Site
      • North Miami, Florida, United States, 33161
        • Research Site
      • South Miami, Florida, United States, 33143
        • Research Site
      • West Palm Beach, Florida, United States, 33401
        • Research Site
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Research Site
      • Savannah, Georgia, United States, 31406
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60613
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Research Site
    • Kansas
      • Arkansas City, Kansas, United States, 67005
        • Research Site
      • Newton, Kansas, United States, 67114
        • Research Site
      • Wichita, Kansas, United States, 67207
        • Research Site
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Research Site
      • New Orleans, Louisiana, United States, 70112
        • Research Site
      • New Orleans, Louisiana, United States, 70115
        • Research Site
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720
        • Research Site
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Research Site
    • Mississippi
      • Jackson, Mississippi, United States, 39213
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Research Site
      • Las Vegas, Nevada, United States, 89106
        • Research Site
      • North Las Vegas, Nevada, United States, 89030
        • Research Site
    • New York
      • Brooklyn, New York, United States, 11203
        • Research Site
    • North Carolina
      • Greensboro, North Carolina, United States, 27405
        • Research Site
      • New Bern, North Carolina, United States, 28562
        • Research Site
      • Raleigh, North Carolina, United States, 27612
        • Research Site
    • Ohio
      • Columbus, Ohio, United States, 43231
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Research Site
    • Pennsylvania
      • Jefferson Hills, Pennsylvania, United States, 15025
        • Research Site
      • Jenkintown, Pennsylvania, United States, 19046
        • Research Site
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Research Site
    • Texas
      • Houston, Texas, United States, 77030
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Research Site
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Research Site
    • Washington
      • Spokane, Washington, United States, 99207
        • Research Site
      • Tacoma, Washington, United States, 98405
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Warner Chilcott

Investigators

  • Study Director: John Caminis, MD, Warner Chilcott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

April 28, 2010

First Submitted That Met QC Criteria

April 29, 2010

First Posted (Estimate)

April 30, 2010

Study Record Updates

Last Update Posted (Estimate)

January 27, 2012

Last Update Submitted That Met QC Criteria

December 21, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR-04809

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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