Urogential Chlamydia Trachomatis InfectionPhase 3NCT01113931

Treatment of Chlamydia Infection Comparing WC2031 Tablets With Vibramycin

A Phase 3 study testing Doxycyline Hyclate tablet and Vibramycin (doxycyline hyclate) capsule in people with Urogential Chlamydia Trachomatis Infection, run by Warner Chilcott at 43 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 19 to 45 years
Conditions the study is for: Urogential Chlamydia Trachomatis Infection
What is being tested?: Doxycyline Hyclate tablet and Vibramycin (doxycyline hyclate) capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 495 participants
Where: 43 sitesUnited States
Study dates: Apr 2010to Oct 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

43 sites in 1 country.

City, postcode or hospital

43 sites in 1 country

United States43 sites

Research Site
Anaheim, California, 92805
Research Site
Arkansas City, Kansas, 67005
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Birmingham, Alabama, 35294
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Boca Raton, Florida, 33432
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Boynton Beach, Florida, 33472
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Brooklyn, New York, 11203
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Chicago, Illinois, 60613
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Columbus, Ohio, 43231
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Decatur, Georgia, 30033
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Detroit, Michigan, 48201
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Fall River, Massachusetts, 02720
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Foley, Alabama, 36535
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Fresno, California, 93726
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Greensboro, North Carolina, 27405
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Houston, Texas, 77030
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Indianapolis, Indiana, 46202
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Jackson, Mississippi, 39213
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Jefferson Hills, Pennsylvania, 15025
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Jenkintown, Pennsylvania, 19046
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Las Vegas, Nevada, 89106
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Las Vegas, Nevada, 89109
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Los Angeles, California, 90007
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Margate, Florida, 33063
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Marrero, Louisiana, 70072
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Myrtle Beach, South Carolina, 29572
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New Bern, North Carolina, 28562
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New Orleans, Louisiana, 70112
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New Orleans, Louisiana, 70115
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Newton, Kansas, 67114
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Norfolk, Virginia, 23507
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North Las Vegas, Nevada, 89030
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North Miami, Florida, 33161
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Oklahoma City, Oklahoma, 73120
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Raleigh, North Carolina, 27612
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San Antonio, Texas, 78229
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San Diego, California, 92108
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Savannah, Georgia, 31406
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South Miami, Florida, 33143
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Spokane, Washington, 99207
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Tacoma, Washington, 98405
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Tucson, Arizona, 85710
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West Palm Beach, Florida, 33401
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Wichita, Kansas, 67207

Other trials in United States

About this study

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

Conditions: Urogential Chlamydia Trachomatis Infection
Being tested: Doxycyline Hyclate tablet, Vibramycin (doxycyline hyclate) capsule
Keywords: Chlamydia
Medical subject headings: Chlamydia Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Doxycyline Hyclate tabletDrug
Also called WC2031
200 mg tablet, once daily for 7 days
Vibramycin (doxycyline hyclate) capsuleDrug
Also called doxycycline
100 mg capsule, twice daily for 7 days, over-encapsulated

Study groups in NCT01113931
Study group	Role	What they receive
Doxycycline Hyclate 200 mg tablet	Experimental	Once daily Receives: Drug: Doxycyline Hyclate tablet
Vibramycin 100 mg capsule	Active comparator	Twice daily Receives: Drug: Vibramycin (doxycyline hyclate) capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Day 28

Secondary outcomes (3)

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
Measured: 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
Measured: 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
Measured: Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Oct 2010

First posted30 Apr 2010 (estimated)
Study startApr 2010
Primary completionOct 2010
Study completionOct 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Urogential Chlamydia Trachomatis InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 495 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01113931
Sponsor's protocol ID: PR-04809
Status last verified: Dec 2011
First submitted: 28 Apr 2010
Last updated: 27 Jan 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 22431798

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01113931
Acronym / sponsor ID: PR-04809
Conditions: Urogential Chlamydia Trachomatis Infection
Keywords: Chlamydia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 495 participants (actual)
Lead sponsor: Warner ChilcottIndustry (pharma, biotech, devices)
Study start: Apr 2010
Primary completion: Oct 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 30 Apr 2010 (estimated)
Results: Posted 27 Jan 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Doxycycline Hyclate 200 mg tablet	Experimental	Drug: Doxycyline Hyclate tabletOnce daily
Vibramycin 100 mg capsule	Active comparator	Drug: Vibramycin (doxycyline hyclate) capsuleTwice daily

Who may qualify

Ages: 19 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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)

Key exclusion criteria (6 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Doxycyline Hyclate tabletAlso: WC2031200 mg tablet, once daily for 7 days	Drug	Doxycycline Hyclate 200 mg tablet
Vibramycin (doxycyline hyclate) capsuleAlso: doxycycline100 mg capsule, twice daily for 7 days, over-encapsulated	Drug	Vibramycin 100 mg capsule

Primary outcome

Microbiological Cure Rate
Time frame: 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

3 secondary outcomes

Microbiological Cure and Clinical Cure of C. Trachomatis, Day 28, Clinically Evaluable Population, Percentage Participants Cured
Time frame: End of Study (Day 28)
Microbiological Cure C. Trachomatis and M. Genitalium, M. Genitalium Coinfected Population, Day 28, Percentage Participants Cured
Time frame: End of Study (Day 28)
Microbiological Cure C. Trachomatis, N. Gonorrhoea Negative Population, Day 28, Percentage Participants Cured
Time frame: Day 28

Results and safety

Results posted to the registry on 27 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Doxycycline Hyclate	247	228
Vibramycin	248	231

Primary outcome: Microbiological Cure Rate

Time frame: Day 28. Number (95% Confidence Interval). Unit: percentage of participants cured

Measure	Doxycycline Hyclate n = 157	Vibramycin n = 168
Value	94.9 (91.5 to 98.3)	94.6 (91.2 to 98.0)

Doxycycline Hyclate vs Vibramycin: Difference in Percent Cure Rates: 0.3 (95% CI -4.6 to 5.1)

Population analysed: mITT Population - all randomized subjects who had positive NAAT for C. trachomatis at Baseline and took at least one dose of study drug.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 28 day treatment period. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Doxycycline Hyclate	0 of 246 (0%)	84 of 246 (34.1%)	Not reported
Vibramycin	0 of 248 (0%)	129 of 248 (52%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22431798Geisler 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Caminis, MD study director

Warner Chilcott

43 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Microbiological Cure Rate (time frame: Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01113931, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2012.