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Treatment of Chlamydia Infection Comparing WC2031 Tablets With Vibramycin

Primary Purpose

Urogential Chlamydia Trachomatis Infection

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Doxycyline Hyclate tablet
Vibramycin (doxycyline hyclate) capsule
Sponsored by
Warner Chilcott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urogential Chlamydia Trachomatis Infection focused on measuring Chlamydia

Eligibility Criteria

19 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Doxycycline Hyclate 200 mg tablet

Vibramycin 100 mg capsule

Arm Description

Once daily

Twice daily

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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

Full Information

First Posted
April 28, 2010
Last Updated
December 21, 2011
Sponsor
Warner Chilcott
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1. Study Identification

Unique Protocol Identification Number
NCT01113931
Brief Title
Treatment of Chlamydia Infection Comparing WC2031 Tablets With Vibramycin
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 Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Warner Chilcott

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urogential Chlamydia Trachomatis Infection
Keywords
Chlamydia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
495 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Doxycycline Hyclate 200 mg tablet
Arm Type
Experimental
Arm Description
Once daily
Arm Title
Vibramycin 100 mg capsule
Arm Type
Active Comparator
Arm Description
Twice daily
Intervention Type
Drug
Intervention Name(s)
Doxycyline Hyclate tablet
Other Intervention Name(s)
WC2031
Intervention Description
200 mg tablet, once daily for 7 days
Intervention Type
Drug
Intervention Name(s)
Vibramycin (doxycyline hyclate) capsule
Other Intervention Name(s)
doxycycline
Intervention Description
100 mg capsule, twice daily for 7 days, over-encapsulated
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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)
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)
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Caminis, MD
Organizational Affiliation
Warner Chilcott
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Research Site
City
Foley
State/Province
Alabama
ZIP/Postal Code
36535
Country
United States
Facility Name
Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Research Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Research Site
City
Fresno
State/Province
California
ZIP/Postal Code
93726
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90007
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Research Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33432
Country
United States
Facility Name
Research Site
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Research Site
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Facility Name
Research Site
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Research Site
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Research Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Research Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Research Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60613
Country
United States
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Research Site
City
Arkansas City
State/Province
Kansas
ZIP/Postal Code
67005
Country
United States
Facility Name
Research Site
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Research Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Research Site
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Research Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Research Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Research Site
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Research Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Research Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39213
Country
United States
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Research Site
City
North Las Vegas
State/Province
Nevada
ZIP/Postal Code
89030
Country
United States
Facility Name
Research Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Research Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Facility Name
Research Site
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Research Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43231
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Research Site
City
Jefferson Hills
State/Province
Pennsylvania
ZIP/Postal Code
15025
Country
United States
Facility Name
Research Site
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Research Site
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Research Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Research Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99207
Country
United States
Facility Name
Research Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22431798
Citation
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.
Results Reference
derived

Learn more about this trial

Treatment of Chlamydia Infection Comparing WC2031 Tablets With Vibramycin

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