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
Results First Received: November 9, 2011  
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
Condition: Urogential Chlamydia Trachomatis Infection
Interventions: Drug: Doxycyline Hyclate tablet
Drug: Vibramycin (doxycyline hyclate) capsule

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment period began 7 Apr '10

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Doxycycline Hyclate Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
Vibramycin Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet

Participant Flow:   Overall Study
    Doxycycline Hyclate     Vibramycin  
STARTED     247     248  
Safety Population     246 [1]   248  
mITT Population     188     190  
COMPLETED     228     231  
NOT COMPLETED     19     17  
Adverse Event                 2                 2  
Physician Decision                 0                 2  
Lost to Follow-up                 12                 9  
Various                 2                 4  
Withdrawal by Subject                 3                 0  
[1] 1 subject did not take any study medication



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Doxycycline Hyclate Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
Vibramycin Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
Total Total of all reporting groups

Baseline Measures
    Doxycycline Hyclate     Vibramycin     Total  
Number of Participants  
[units: participants]
  247     248     495  
Age [1]
[units: years]
Mean ± Standard Deviation
  24.1  ± 4.9     23.9  ± 4.9     24.0  ± 4.9  
Age, Customized [1]
[units: participants]
     
<30 years     163     170     333  
Between 30 and 40 years     22     18     40  
>40 years     3     2     5  
Gender [1]
[units: participants]
     
Female     115     118     233  
Male     73     72     145  
Ethnicity (NIH/OMB) [1]
[units: Participants]
     
Hispanic or Latino     33     44     77  
Not Hispanic or Latino     155     146     301  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB) [1]
[units: Participants]
     
American Indian or Alaska Native     2     1     3  
Asian     3     1     4  
Native Hawaiian or Other Pacific Islander     3     1     4  
Black or African American     109     104     213  
White     61     73     134  
More than one race     10     10     20  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     247     248     495  
[1] mITT Population



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Microbiological Cure Rate   [ Time Frame: Day 28 ]

2.  Secondary:   Microbiological Cure and Clinical Cure of C. Trachomatis, Day 28, Clinically Evaluable Population, Percentage Participants Cured   [ Time Frame: End of Study (Day 28) ]

3.  Secondary:   Microbiological Cure C. Trachomatis and M. Genitalium, M. Genitalium Coinfected Population, Day 28, Percentage Participants Cured   [ Time Frame: End of Study (Day 28) ]

4.  Secondary:   Microbiological Cure C. Trachomatis, N. Gonorrhoea Negative Population, Day 28, Percentage Participants Cured   [ Time Frame: Day 28 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Grexan Wulff, Manager Regulatory Affairs
Organization: Warner Chilcott
phone: 973-442-3376
e-mail: gwulff@wcrx.com


No publications provided by Warner Chilcott

Publications automatically indexed to this study:

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