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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doxycycline Hyclate 200 mg tablet | Experimental | Once daily |
|
| Vibramycin 100 mg capsule | Active Comparator | Twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxycyline Hyclate tablet | Drug | 200 mg tablet, once daily for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Microbiological Cure Rate | 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 | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiological Cure and Clinical Cure of C. Trachomatis, Day 28, Clinically Evaluable Population, Percentage Participants Cured | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Caminis, MD | Warner Chilcott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35294 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22431798 | Derived | 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. |
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Enrollment period began 7 Apr '10
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| ID | Title | Description |
|---|---|---|
| FG000 | Doxycycline Hyclate | Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule |
| FG001 | Vibramycin | Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Vibramycin (doxycyline hyclate) capsule | Drug | 100 mg capsule, twice daily for 7 days, over-encapsulated |
|
|
| End of Study (Day 28) |
| Microbiological Cure C. Trachomatis and M. Genitalium, M. Genitalium Coinfected Population, Day 28, Percentage Participants Cured | 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 | End of Study (Day 28) |
| Microbiological Cure C. Trachomatis, N. Gonorrhoea Negative Population, Day 28, Percentage Participants Cured | 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 | Day 28 |
| Foley |
| Alabama |
| 36535 |
| United States |
| Research Site | Tucson | Arizona | 85710 | United States |
| Research Site | Anaheim | California | 92805 | United States |
| Research Site | Fresno | California | 93726 | United States |
| Research Site | Los Angeles | California | 90007 | United States |
| Research Site | San Diego | California | 92108 | United States |
| Research Site | Boca Raton | Florida | 33432 | United States |
| Research Site | Boynton Beach | Florida | 33472 | United States |
| Research Site | Margate | Florida | 33063 | United States |
| Research Site | North Miami | Florida | 33161 | United States |
| Research Site | South Miami | Florida | 33143 | United States |
| Research Site | West Palm Beach | Florida | 33401 | United States |
| Research Site | Decatur | Georgia | 30033 | United States |
| Research Site | Savannah | Georgia | 31406 | United States |
| Research Site | Chicago | Illinois | 60613 | United States |
| Research Site | Indianapolis | Indiana | 46202 | United States |
| Research Site | Arkansas City | Kansas | 67005 | United States |
| Research Site | Newton | Kansas | 67114 | United States |
| Research Site | Wichita | Kansas | 67207 | United States |
| Research Site | Marrero | Louisiana | 70072 | United States |
| Research Site | New Orleans | Louisiana | 70112 | United States |
| Research Site | New Orleans | Louisiana | 70115 | United States |
| Research Site | Fall River | Massachusetts | 02720 | United States |
| Research Site | Detroit | Michigan | 48201 | United States |
| Research Site | Jackson | Mississippi | 39213 | United States |
| Research Site | Las Vegas | Nevada | 89106 | United States |
| Research Site | Las Vegas | Nevada | 89109 | United States |
| Research Site | North Las Vegas | Nevada | 89030 | United States |
| Research Site | Brooklyn | New York | 11203 | United States |
| Research Site | Greensboro | North Carolina | 27405 | United States |
| Research Site | New Bern | North Carolina | 28562 | United States |
| Research Site | Raleigh | North Carolina | 27612 | United States |
| Research Site | Columbus | Ohio | 43231 | United States |
| Research Site | Oklahoma City | Oklahoma | 73120 | United States |
| Research Site | Jefferson Hills | Pennsylvania | 15025 | United States |
| Research Site | Jenkintown | Pennsylvania | 19046 | United States |
| Research Site | Myrtle Beach | South Carolina | 29572 | United States |
| Research Site | Houston | Texas | 77030 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| Research Site | Norfolk | Virginia | 23507 | United States |
| Research Site | Spokane | Washington | 99207 | United States |
| Research Site | Tacoma | Washington | 98405 | United States |
| Safety Population |
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| mITT Population |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Doxycycline Hyclate | Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule |
| BG001 | Vibramycin | Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | mITT Population | Mean | Standard Deviation | years |
| ||||||||||||||
| Age, Customized | mITT Population | Number | participants |
| |||||||||||||||
| Gender | mITT Population | Number | participants |
| |||||||||||||||
| Ethnicity (NIH/OMB) | mITT Population | Number | Participants |
| |||||||||||||||
| Race (NIH/OMB) | mITT Population | Number | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Microbiological Cure Rate | 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 | mITT Population - all randomized subjects who had positive NAAT for C. trachomatis at Baseline and took at least one dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants cured | Day 28 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Microbiological Cure and Clinical Cure of C. Trachomatis, Day 28, Clinically Evaluable Population, Percentage Participants Cured | 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 | Clinically Evaluable Population | Posted | Number | Percentage Particpants Cured | End of Study (Day 28) |
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| Secondary | Microbiological Cure C. Trachomatis and M. Genitalium, M. Genitalium Coinfected Population, Day 28, Percentage Participants Cured | 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 | M. genitalium Coinfected Population | Posted | Number | Percentage Participants Cured | End of Study (Day 28) |
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| Secondary | Microbiological Cure C. Trachomatis, N. Gonorrhoea Negative Population, Day 28, Percentage Participants Cured | 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 | N. gonorrhoea Population. Only subjects with an evaluable outcome are included in the analysis. | Posted | Number | 95% Confidence Interval | Percentage Participants Cured | Day 28 |
|
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28 day treatment period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Doxycycline Hyclate | Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule | 0 | 246 | 84 | 246 | ||
| EG001 | Vibramycin | Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet | 0 | 248 | 129 | 248 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Vaginitis Bacterial | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Vulvovaginal Mycotic Infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grexan Wulff, Manager Regulatory Affairs | Warner Chilcott | 973-442-3376 | gwulff@wcrx.com |
| ID | Term |
|---|---|
| D002690 | Chlamydia Infections |
| ID | Term |
|---|---|
| D002694 | Chlamydiaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D004318 | Doxycycline |
| D002214 | Capsules |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Between 30 and 40 years |
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| >40 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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