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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

April 28, 2010
December 21, 2011
April 2010
October 2010   (final data collection date for primary outcome measure)
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
Microbiological Cure [ Time Frame: Day 28 (-3/+7 days) ] [ Designated as safety issue: No ]
Negative nucleic acid amplification test (NAAT)
Complete list of historical versions of study NCT01113931 on ClinicalTrials.gov Archive Site
  • 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
Safety [ Time Frame: End of Treatment (day 8), End of Study (day 28) ] [ Designated as safety issue: Yes ]
Adverse Event (AE) monitoring volunteered and thru general questioning, changes in vital signs and lab results.
Not Provided
Not Provided
 
Treatment of Chlamydia Infection Comparing WC2031 Tablets With Vibramycin
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Urogential Chlamydia Trachomatis Infection
  • Drug: Doxycyline Hyclate tablet
    200 mg tablet, once daily for 7 days
    Other Name: WC2031
  • Drug: Vibramycin (doxycyline hyclate) capsule
    100 mg capsule, twice daily for 7 days, over-encapsulated
    Other Name: doxycycline
  • Experimental: Doxycycline Hyclate 200 mg tablet
    Once daily
    Intervention: Drug: Doxycyline Hyclate tablet
  • Active Comparator: Vibramycin 100 mg capsule
    Twice daily
    Intervention: Drug: Vibramycin (doxycyline hyclate) capsule
Geisler WM, Koltun WD, Abdelsayed N, Burigo J, Mena L, Taylor SN, Batteiger BE, Thurman AR, Hook EW 3rd, Vaughn TA, Annett MP, Muenzen RA, Caminis J. 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 trial. Clin Infect Dis. 2012 Jul;55(1):82-8. doi: 10.1093/cid/cis291. Epub 2012 Mar 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
495
October 2010
October 2010   (final data collection date for primary outcome measure)

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
Both
19 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01113931
PR-04809
No
Warner Chilcott
Warner Chilcott
Not Provided
Study Director: John Caminis, MD Warner Chilcott
Warner Chilcott
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP