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

  Show 43 Study Locations
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 15, 2014