Treatment of Chlamydia Infection Comparing WC2031 Tablets With Vibramycin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT01113931
First received: April 28, 2010
Last updated: December 21, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Urogential Chlamydia Trachomatis Infection
Drug: Doxycyline Hyclate tablet
Drug: Vibramycin (doxycyline hyclate) capsule
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • Microbiological Cure Rate [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    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:
  • Microbiological Cure and Clinical Cure of C. Trachomatis, Day 28, Clinically Evaluable Population, Percentage Participants Cured [ Time Frame: End of Study (Day 28) ] [ Designated as safety issue: No ]
    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 [ Time Frame: End of Study (Day 28) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    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


Enrollment: 495
Study Start Date: April 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Doxycycline Hyclate 200 mg tablet
Once daily
Drug: Doxycyline Hyclate tablet
200 mg tablet, once daily for 7 days
Other Name: 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 Name: doxycycline

  Eligibility

Ages Eligible for Study:   19 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01113931

  Hide Study Locations
Locations
United States, Alabama
Research Site
Birmingham, Alabama, United States, 35294
Research Site
Foley, Alabama, United States, 36535
United States, Arizona
Research Site
Tucson, Arizona, United States, 85710
United States, California
Research Site
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
United States, Florida
Research Site
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
United States, Georgia
Research Site
Decatur, Georgia, United States, 30033
Research Site
Savannah, Georgia, United States, 31406
United States, Illinois
Research Site
Chicago, Illinois, United States, 60613
United States, Indiana
Research Site
Indianapolis, Indiana, United States, 46202
United States, Kansas
Research Site
Arkansas City, Kansas, United States, 67005
Research Site
Newton, Kansas, United States, 67114
Research Site
Wichita, Kansas, United States, 67207
United States, Louisiana
Research Site
Marrero, Louisiana, United States, 70072
Research Site
New Orleans, Louisiana, United States, 70112
Research Site
New Orleans, Louisiana, United States, 70115
United States, Massachusetts
Research Site
Fall River, Massachusetts, United States, 02720
United States, Michigan
Research Site
Detroit, Michigan, United States, 48201
United States, Mississippi
Research Site
Jackson, Mississippi, United States, 39213
United States, Nevada
Research Site
Las Vegas, Nevada, United States, 89106
Research Site
Las Vegas, Nevada, United States, 89109
Research Site
North Las Vegas, Nevada, United States, 89030
United States, New York
Research Site
Brooklyn, New York, United States, 11203
United States, North Carolina
Research Site
Greensboro, North Carolina, United States, 27405
Research Site
New Bern, North Carolina, United States, 28562
Research Site
Raleigh, North Carolina, United States, 27612
United States, Ohio
Research Site
Columbus, Ohio, United States, 43231
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States, 73120
United States, Pennsylvania
Research Site
Jefferson Hills, Pennsylvania, United States, 15025
Research Site
Jenkintown, Pennsylvania, United States, 19046
United States, South Carolina
Research Site
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
Research Site
Houston, Texas, United States, 77030
Research Site
San Antonio, Texas, United States, 78229
United States, Virginia
Research Site
Norfolk, Virginia, United States, 23507
United States, Washington
Research Site
Spokane, Washington, United States, 99207
Research Site
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: John Caminis, MD Warner Chilcott
  More Information

No publications provided by Warner Chilcott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT01113931     History of Changes
Other Study ID Numbers: PR-04809
Study First Received: April 28, 2010
Results First Received: November 9, 2011
Last Updated: December 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Warner Chilcott:
Chlamydia

Additional relevant MeSH terms:
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Doxycycline
Doxycycline hyclate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on April 23, 2014