Treatment of Chlamydia Infection Comparing WC2031 Tablets With Vibramycin

• Sponsor: Warner Chilcott (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01113931
• Collaborator: (none)
• Enrollment: 495
• Locations: 43
• Arms: 2
• Duration (Months): 6
• Patients Per Site: 11.5
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urogential Chlamydia Trachomatis Infection	Drug: Doxycyline Hyclate tablet; Drug: Vibramycin (doxycyline hyclate) capsule	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 495 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Doxycycline Hyclate 200 mg tablet Once daily	Drug: Doxycyline Hyclate tablet; 200 mg tablet, once daily for 7 days; Other Names: WC2031
Active Comparator: Vibramycin 100 mg capsule Twice daily	Drug: Vibramycin (doxycyline hyclate) capsule; 100 mg capsule, twice daily for 7 days, over-encapsulated; Other Names: doxycycline

Outcome Measures

Primary Outcome Measures

1. Microbiological Cure Rate [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

Secondary Outcome Measures

1. Microbiological Cure and Clinical Cure of C. Trachomatis, Day 28, Clinically Evaluable Population, Percentage Participants Cured [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

2. Microbiological Cure C. Trachomatis and M. Genitalium, M. Genitalium Coinfected Population, Day 28, Percentage Participants Cured [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

3. Microbiological Cure C. Trachomatis, N. Gonorrhoea Negative Population, Day 28, Percentage Participants Cured [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Birmingham	Alabama	United States	35294
2	Research Site	Foley	Alabama	United States	36535
3	Research Site	Tucson	Arizona	United States	85710
4	Research Site	Anaheim	California	United States	92805
5	Research Site	Fresno	California	United States	93726
6	Research Site	Los Angeles	California	United States	90007
7	Research Site	San Diego	California	United States	92108
8	Research Site	Boca Raton	Florida	United States	33432
9	Research Site	Boynton Beach	Florida	United States	33472
10	Research Site	Margate	Florida	United States	33063
11	Research Site	North Miami	Florida	United States	33161
12	Research Site	South Miami	Florida	United States	33143
13	Research Site	West Palm Beach	Florida	United States	33401
14	Research Site	Decatur	Georgia	United States	30033
15	Research Site	Savannah	Georgia	United States	31406
16	Research Site	Chicago	Illinois	United States	60613
17	Research Site	Indianapolis	Indiana	United States	46202
18	Research Site	Arkansas City	Kansas	United States	67005
19	Research Site	Newton	Kansas	United States	67114
20	Research Site	Wichita	Kansas	United States	67207
21	Research Site	Marrero	Louisiana	United States	70072
22	Research Site	New Orleans	Louisiana	United States	70112
23	Research Site	New Orleans	Louisiana	United States	70115
24	Research Site	Fall River	Massachusetts	United States	02720
25	Research Site	Detroit	Michigan	United States	48201
26	Research Site	Jackson	Mississippi	United States	39213
27	Research Site	Las Vegas	Nevada	United States	89106
28	Research Site	Las Vegas	Nevada	United States	89109
29	Research Site	North Las Vegas	Nevada	United States	89030
30	Research Site	Brooklyn	New York	United States	11203
31	Research Site	Greensboro	North Carolina	United States	27405
32	Research Site	New Bern	North Carolina	United States	28562
33	Research Site	Raleigh	North Carolina	United States	27612
34	Research Site	Columbus	Ohio	United States	43231
35	Research Site	Oklahoma City	Oklahoma	United States	73120
36	Research Site	Jefferson Hills	Pennsylvania	United States	15025
37	Research Site	Jenkintown	Pennsylvania	United States	19046
38	Research Site	Myrtle Beach	South Carolina	United States	29572
39	Research Site	Houston	Texas	United States	77030
40	Research Site	San Antonio	Texas	United States	78229
41	Research Site	Norfolk	Virginia	United States	23507
42	Research Site	Spokane	Washington	United States	99207
43	Research Site	Tacoma	Washington	United States	98405

Sponsors and Collaborators

• Warner Chilcott

Investigators

• Study Director: John Caminis, MD, Warner Chilcott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Warner Chilcott
• ClinicalTrials.gov Identifier: NCT01113931
• Other Study ID Numbers: PR-04809
• First Posted: Apr 30, 2010
• Last Update Posted: Jan 27, 2012
• Last Verified: Dec 1, 2011

• Keywords provided by Warner Chilcott: Chlamydia
• Additional relevant MeSH terms: Infections; Communicable Diseases; Chlamydia Infections; Doxycycline

Study Results

Participant Flow

Recruitment Details	Enrollment period began 7 Apr '10

Arm/Group Title	Doxycycline Hyclate	Vibramycin
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	248
mITT Population	188	190
COMPLETED	228	231
NOT COMPLETED	19	17

Baseline Characteristics

Arm/Group Title	Doxycycline Hyclate	Vibramycin	Total
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 Participants	247	248	495
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	24.1 (4.9)	23.9 (4.9)	24.0 (4.9)
Age, Customized (participants) [Number]
<30 years	163 66%	170 68.5%	333 67.3%
Between 30 and 40 years	22 8.9%	18 7.3%	40 8.1%
>40 years	3 1.2%	2 0.8%	5 1%
Gender (participants) [Number]
Female	115 46.6%	118 47.6%	233 47.1%
Male	73 29.6%	72 29%	145 29.3%
Ethnicity (NIH/OMB) (Number) [Number]
Hispanic or Latino	33 13.4%	44 17.7%	77 15.6%
Not Hispanic or Latino	155 62.8%	146 58.9%	301 60.8%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Number) [Number]
American Indian or Alaska Native	2 0.8%	1 0.4%	3 0.6%
Asian	3 1.2%	1 0.4%	4 0.8%
Native Hawaiian or Other Pacific Islander	3 1.2%	1 0.4%	4 0.8%
Black or African American	109 44.1%	104 41.9%	213 43%
White	61 24.7%	73 29.4%	134 27.1%
More than one race	10 4%	10 4%	20 4%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	247 100%	248 100%	495 100%

Outcome Measures

1. Primary Outcome

Title	Microbiological Cure Rate
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

Outcome Measure Data

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
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
Measure Participants	157	168
Number (95% Confidence Interval) [percentage of participants cured]	94.9 38.4%	94.6 38.1%

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent Cure Rates
	Estimated Value	0.3
	Confidence Interval	(2-Sided) 95%; -4.6 to 5.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Microbiological Cure and Clinical Cure of C. Trachomatis, Day 28, Clinically Evaluable Population, Percentage Participants Cured
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)

Outcome Measure Data

Analysis Population Description

Clinically Evaluable Population

Arm/Group Title	Doxycycline Hyclate	Vibramycin
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
Measure Participants	69	83
Number [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
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)

Outcome Measure Data

Analysis Population Description

M. genitalium Coinfected Population

Arm/Group Title	Doxycycline Hyclate	Vibramycin
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
Measure Participants	15	12
Number [Percentage Participants Cured]	38.5 15.6%	18.2 7.3%

4. Secondary Outcome

Title	Microbiological Cure C. Trachomatis, N. Gonorrhoea Negative Population, Day 28, Percentage Participants Cured
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

Outcome Measure Data

Analysis Population Description

N. gonorrhoea Population. Only subjects with an evaluable outcome are included in the analysis.

Arm/Group Title	Doxycycline Hyclate	Vibramycin
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
Measure Participants	187	186
Number (95% Confidence Interval) [Percentage Participants Cured]	94.9 38.4%	94.6 38.1%

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent Cure Rates
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 95%; -4.6 to 5.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	28 day treatment period
Arm/Group Title	Doxycycline Hyclate		Vibramycin
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Doxycycline Hyclate		Vibramycin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/246 (0%)		0/248 (0%)
Other (Not Including Serious) Adverse Events
	Doxycycline Hyclate		Vibramycin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	84/246 (34.1%)		129/248 (52%)
Gastrointestinal disorders
Nausea	33/246 (13.4%)	33	51/248 (20.6%)	51
Vomiting	20/246 (8.1%)	20	30/248 (12.1%)	30
Diarrhoea	8/246 (3.3%)	8	11/248 (4.4%)	11
Abdominal Pain Upper	5/246 (2%)	5	13/248 (5.2%)	13
Infections and infestations
Vaginitis Bacterial	8/246 (3.3%)	8	5/248 (2%)	5
Vulvovaginal Mycotic Infection	5/246 (2%)	5	4/248 (1.6%)	4
Nervous system disorders
Headache	5/246 (2%)	5	15/248 (6%)	15

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.