Trial Outcomes & Findings for Treatment of Chlamydia Infection Comparing WC2031 Tablets With Vibramycin (NCT NCT01113931)
NCT ID: NCT01113931
Last Updated: 2012-01-27
Results Overview
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
COMPLETED
PHASE3
495 participants
Day 28
2012-01-27
Participant Flow
Enrollment period began 7 Apr '10
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
247
|
248
|
|
Overall Study
Safety Population
|
246
|
248
|
|
Overall Study
mITT Population
|
188
|
190
|
|
Overall Study
COMPLETED
|
228
|
231
|
|
Overall Study
NOT COMPLETED
|
19
|
17
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
12
|
9
|
|
Overall Study
Various
|
2
|
4
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
Baseline Characteristics
Treatment of Chlamydia Infection Comparing WC2031 Tablets With Vibramycin
Baseline characteristics by cohort
| Measure |
Doxycycline Hyclate
n=247 Participants
Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
|
Vibramycin
n=248 Participants
Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
|
Total
n=495 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
24.1 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
23.9 years
STANDARD_DEVIATION 4.9 • n=7 Participants
|
24.0 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
|
Age, Customized
<30 years
|
163 participants
n=5 Participants
|
170 participants
n=7 Participants
|
333 participants
n=5 Participants
|
|
Age, Customized
Between 30 and 40 years
|
22 participants
n=5 Participants
|
18 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Age, Customized
>40 years
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Gender
Female
|
115 participants
n=5 Participants
|
118 participants
n=7 Participants
|
233 participants
n=5 Participants
|
|
Gender
Male
|
73 participants
n=5 Participants
|
72 participants
n=7 Participants
|
145 participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
33 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
155 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
301 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
109 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
213 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
247 participants
n=5 Participants
|
248 participants
n=7 Participants
|
495 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: mITT Population - all randomized subjects who had positive NAAT for C. trachomatis at Baseline and took at least one dose of study drug.
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
Outcome measures
| Measure |
Doxycycline Hyclate
n=157 Participants
Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
|
Vibramycin
n=168 Participants
Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
|
|---|---|---|
|
Microbiological Cure Rate
|
94.9 percentage of participants cured
Interval 91.5 to 98.3
|
94.6 percentage of participants cured
Interval 91.2 to 98.0
|
SECONDARY outcome
Timeframe: End of Study (Day 28)Population: Clinically Evaluable Population
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
Outcome measures
| Measure |
Doxycycline Hyclate
n=69 Participants
Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
|
Vibramycin
n=83 Participants
Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
|
|---|---|---|
|
Microbiological Cure and Clinical Cure of C. Trachomatis, Day 28, Clinically Evaluable Population, Percentage Participants Cured
|
80.0 Percentage Particpants Cured
|
68.6 Percentage Particpants Cured
|
SECONDARY outcome
Timeframe: End of Study (Day 28)Population: M. genitalium Coinfected Population
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
Outcome measures
| Measure |
Doxycycline Hyclate
n=15 Participants
Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
|
Vibramycin
n=12 Participants
Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
|
|---|---|---|
|
Microbiological Cure C. Trachomatis and M. Genitalium, M. Genitalium Coinfected Population, Day 28, Percentage Participants Cured
|
38.5 Percentage Participants Cured
|
18.2 Percentage Participants Cured
|
SECONDARY outcome
Timeframe: Day 28Population: N. gonorrhoea Population. Only subjects with an evaluable outcome are included in the analysis.
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
Outcome measures
| Measure |
Doxycycline Hyclate
n=187 Participants
Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
|
Vibramycin
n=186 Participants
Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
|
|---|---|---|
|
Microbiological Cure C. Trachomatis, N. Gonorrhoea Negative Population, Day 28, Percentage Participants Cured
|
94.9 Percentage Participants Cured
Interval 91.4 to 98.3
|
94.6 Percentage Participants Cured
Interval 91.2 to 98.0
|
Adverse Events
Doxycycline Hyclate
Vibramycin
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Doxycycline Hyclate
n=246 participants at risk
Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
|
Vibramycin
n=248 participants at risk
Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
13.4%
33/246 • Number of events 33 • 28 day treatment period
|
20.6%
51/248 • Number of events 51 • 28 day treatment period
|
|
Gastrointestinal disorders
Vomiting
|
8.1%
20/246 • Number of events 20 • 28 day treatment period
|
12.1%
30/248 • Number of events 30 • 28 day treatment period
|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
8/246 • Number of events 8 • 28 day treatment period
|
4.4%
11/248 • Number of events 11 • 28 day treatment period
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
2.0%
5/246 • Number of events 5 • 28 day treatment period
|
5.2%
13/248 • Number of events 13 • 28 day treatment period
|
|
Infections and infestations
Vaginitis Bacterial
|
3.3%
8/246 • Number of events 8 • 28 day treatment period
|
2.0%
5/248 • Number of events 5 • 28 day treatment period
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
2.0%
5/246 • Number of events 5 • 28 day treatment period
|
1.6%
4/248 • Number of events 4 • 28 day treatment period
|
|
Nervous system disorders
Headache
|
2.0%
5/246 • Number of events 5 • 28 day treatment period
|
6.0%
15/248 • Number of events 15 • 28 day treatment period
|
Additional Information
Grexan Wulff, Manager Regulatory Affairs
Warner Chilcott
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60