Treatment of Chlamydia Infection Comparing WC2031 Tablets With Vibramycin

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

495 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Evaluation of the Click Sexual Health Test for the Detection of Neisseria Gonorrhoeae (NG), Trichomonas Vaginalis (TV), and Chlamydia Trachomatis (CT) in Women

NCT04098900

Chlamydial Infection Gonococcal Infection Trichomoniasis

COMPLETED

Clinical Study of a Single-Use, Point-of-Care Molecular Diagnostic Device for the Detection of Neisseria Gonorrhoeae (NG), Trichomonas Vaginalis (TV), and Chlamydia Trachomatis (CT) Utilizing Vaginal Swabs

NCT03596151

Chlamydial Infection Gonorrhoea Trichomoniasis

TERMINATED NA

Impact of the Daily Doxycycline Pre-exposure Prophylaxis (PrEP) on the Incidence of Syphilis, Gonorrhoea and Chlamydia

NCT03709459

STIs Prevention

UNKNOWN

Clinical Study of a Diagnostic Device for NG, TV and CT in Women

NCT03852316

Chlamydial Infection Gonococcal Infection Trichomoniasis

COMPLETED NA

Time to Eradication of Mycoplasma Genitalium and Chlamydia Trachomatis After Treatment Commenced

NCT01661985

Urethritis Cervicitis Genital Mycoplasma Infection +1 more

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urogential Chlamydia Trachomatis Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Doxycycline Hyclate 200 mg tablet

Once daily

Group Type EXPERIMENTAL

Doxycyline Hyclate tablet

Intervention Type DRUG

200 mg tablet, once daily for 7 days

Vibramycin 100 mg capsule

Twice daily

Group Type ACTIVE_COMPARATOR

Vibramycin (doxycyline hyclate) capsule

Intervention Type DRUG

100 mg capsule, twice daily for 7 days, over-encapsulated

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Doxycyline Hyclate tablet

200 mg tablet, once daily for 7 days

Intervention Type DRUG

Vibramycin (doxycyline hyclate) capsule

100 mg capsule, twice daily for 7 days, over-encapsulated

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

WC2031 doxycycline

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No