Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Chlamydia Infection Comparing WC2031 Tablets With Vibramycin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01113931
Recruitment Status : Completed
First Posted : April 30, 2010
Results First Posted : January 27, 2012
Last Update Posted : January 27, 2012
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott

Tracking Information
First Submitted Date  ICMJE April 28, 2010
First Posted Date  ICMJE April 30, 2010
Results First Submitted Date  ICMJE November 9, 2011
Results First Posted Date  ICMJE January 27, 2012
Last Update Posted Date January 27, 2012
Study Start Date  ICMJE April 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2011)
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
Original Primary Outcome Measures  ICMJE
 (submitted: April 29, 2010)
Microbiological Cure [ Time Frame: Day 28 (-3/+7 days) ]
Negative nucleic acid amplification test (NAAT)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2011)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2010)
Safety [ Time Frame: End of Treatment (day 8), End of Study (day 28) ]
Adverse Event (AE) monitoring volunteered and thru general questioning, changes in vital signs and lab results.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Chlamydia Infection Comparing WC2031 Tablets With Vibramycin
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Urogential Chlamydia Trachomatis Infection
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2011)
495
Original Estimated Enrollment  ICMJE
 (submitted: April 29, 2010)
480
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01113931
Other Study ID Numbers  ICMJE PR-04809
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Warner Chilcott
Study Sponsor  ICMJE Warner Chilcott
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: John Caminis, MD Warner Chilcott
PRS Account Warner Chilcott
Verification Date December 2011

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