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Treatment of Chlamydia Infection Comparing WC2031 Tablets With Vibramycin

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Urogential Chlamydia Trachomatis Infection
Interventions Drug: Doxycyline Hyclate tablet
Drug: Vibramycin (doxycyline hyclate) capsule
Enrollment 495
Recruitment Details Enrollment period began 7 Apr '10
Pre-assignment Details  
Arm/Group Title Doxycycline Hyclate Vibramycin
Hide Arm/Group Description Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
Period Title: Overall Study
Started 247 248
Safety Population 246 [1] 248
mITT Population 188 190
Completed 228 231
Not Completed 19 17
Reason Not Completed
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
Arm/Group Title Doxycycline Hyclate Vibramycin Total
Hide Arm/Group Description Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet Total of all reporting groups
Overall Number of Baseline Participants 247 248 495
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 247 participants 248 participants 495 participants
24.1  (4.9) 23.9  (4.9) 24.0  (4.9)
[1]
Measure Description: mITT Population
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 247 participants 248 participants 495 participants
<30 years 163 170 333
Between 30 and 40 years 22 18 40
>40 years 3 2 5
[1]
Measure Description: mITT Population
Gender   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 247 participants 248 participants 495 participants
Female 115 118 233
Male 73 72 145
[1]
Measure Description: mITT Population
Ethnicity (NIH/OMB)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 247 participants 248 participants 495 participants
Hispanic or Latino 33 44 77
Not Hispanic or Latino 155 146 301
Unknown or Not Reported 0 0 0
[1]
Measure Description: mITT Population
Race (NIH/OMB)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 247 participants 248 participants 495 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
[1]
Measure Description: mITT Population
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 247 participants 248 participants 495 participants
247 248 495
1.Primary Outcome
Title Microbiological Cure Rate
Hide Description 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
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population - all randomized subjects who had positive NAAT for C. trachomatis at Baseline and took at least one dose of study drug.
Arm/Group Title Doxycycline Hyclate Vibramycin
Hide Arm/Group Description:
Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
Overall Number of Participants Analyzed 157 168
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants cured
94.9
(91.5 to 98.3)
94.6
(91.2 to 98.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doxycycline Hyclate, Vibramycin
Comments The planned sample size of 480 randomized subjects ensured that approximately 200 subjects per group were included in the primary efficacy analyses. The 20% rate of exclusion was to account for subjects who had a negative test for urogenital C. trachomatis at the Baseline visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percent Cure Rates
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-4.6 to 5.1
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Microbiological Cure and Clinical Cure of C. Trachomatis, Day 28, Clinically Evaluable Population, Percentage Participants Cured
Hide Description 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
Time Frame End of Study (Day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
Clinically Evaluable Population
Arm/Group Title Doxycycline Hyclate Vibramycin
Hide Arm/Group Description:
Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
Overall Number of Participants Analyzed 69 83
Measure Type: Number
Unit of Measure: Percentage Particpants Cured
80.0 68.6
3.Secondary Outcome
Title Microbiological Cure C. Trachomatis and M. Genitalium, M. Genitalium Coinfected Population, Day 28, Percentage Participants Cured
Hide Description 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
Time Frame End of Study (Day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
M. genitalium Coinfected Population
Arm/Group Title Doxycycline Hyclate Vibramycin
Hide Arm/Group Description:
Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
Overall Number of Participants Analyzed 15 12
Measure Type: Number
Unit of Measure: Percentage Participants Cured
38.5 18.2
4.Secondary Outcome
Title Microbiological Cure C. Trachomatis, N. Gonorrhoea Negative Population, Day 28, Percentage Participants Cured
Hide Description 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
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
N. gonorrhoea Population. Only subjects with an evaluable outcome are included in the analysis.
Arm/Group Title Doxycycline Hyclate Vibramycin
Hide Arm/Group Description:
Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
Overall Number of Participants Analyzed 187 186
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage Participants Cured
94.9
(91.4 to 98.3)
94.6
(91.2 to 98.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doxycycline Hyclate, Vibramycin
Comments The planned sample size of 480 randomized subjects ensured that approximately 200 subjects per group were included in the primary efficacy analyses. The 20% rate of exclusion was to account for subjects who had a negative test for urogenital C. trachomatis at the Baseline visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percent Cure Rates
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-4.6 to 5.1
Estimation Comments [Not Specified]
Time Frame 28 day treatment period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Doxycycline Hyclate Vibramycin
Hide Arm/Group Description Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
All-Cause Mortality
Doxycycline Hyclate Vibramycin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Doxycycline Hyclate Vibramycin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/246 (0.00%)      0/248 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Doxycycline Hyclate Vibramycin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   84/246 (34.15%)      129/248 (52.02%)    
Gastrointestinal disorders     
Nausea  1  33/246 (13.41%)  33 51/248 (20.56%)  51
Vomiting  1  20/246 (8.13%)  20 30/248 (12.10%)  30
Diarrhoea  1  8/246 (3.25%)  8 11/248 (4.44%)  11
Abdominal Pain Upper  1  5/246 (2.03%)  5 13/248 (5.24%)  13
Infections and infestations     
Vaginitis Bacterial  1  8/246 (3.25%)  8 5/248 (2.02%)  5
Vulvovaginal Mycotic Infection  1  5/246 (2.03%)  5 4/248 (1.61%)  4
Nervous system disorders     
Headache  1  5/246 (2.03%)  5 15/248 (6.05%)  15
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Grexan Wulff, Manager Regulatory Affairs
Organization: Warner Chilcott
Phone: 973-442-3376
EMail: gwulff@wcrx.com
Layout table for additonal information
Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT01113931    
Other Study ID Numbers: PR-04809
First Submitted: April 28, 2010
First Posted: April 30, 2010
Results First Submitted: November 9, 2011
Results First Posted: January 27, 2012
Last Update Posted: January 27, 2012