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NCT02294682 · ClinicalTrials.gov registry record · Phase 2
A Dose-Ranging Study Evaluating the Efficacy, Safety, and Tolerability of GSK2140944 in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria Gonorrhoeae
A Phase 2 study of Gonorrhea, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 106
- Enrollment target
- 14
- Study locations
NCT02294682: Completed Phase 2 study of Gonorrhea, sponsored by GlaxoSmithKline.
NCT02294682 is a Phase 2 study of Gonorrhea that has completed, run by GlaxoSmithKline. The registered enrollment target is 106 participants, below the 1,435-participant average among 10 other Gonorrhea trials with a reported enrollment target (93% lower). The trial reports 14 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02294682, a Phase 2 study of Gonorrhea, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 106 participants
- Enrollment target
- 14
- Study locations
Study Summary
GSK2140944 has demonstrated in vitro activity against Neisseria (N.) gonorrhoeae, including ciprofloxacin resistant and susceptible strains. This study is a Phase II, randomized, multicenter, open-label, dose ranging study designed to inform the optimal oral dose of GSK2140944 by further characterizing the efficacy, safety, and tolerability in subjects with uncomplicated urogenital gonorrhea due to N. gonorrhoeae. Subjects will be randomly assigned to receive either a single 1500 milligrams (mg) or 3000 mg oral dose of GSK2140944. Appropriate safety and microbiological assessments will be conducted at the Baseline (Day 1) Visit and repeated at the Test-of-Cure (Day 4 to 8) Visit. The study duration will be approximately 1 week. Approximately 60 microbiologically evaluable subjects (30 subjects in each treatment arm) will complete the study if both arms remain active throughout the study.
Primary Outcome
Pre-treatment urogenital, pharyngeal, and rectal swab specimens were obtained for bacteriological culture for neisseria (N.) gonorrhoeae at the Baseline visit. Test- of-Cure was defined by infection site (that is urogenital and, as appropriate, rectal and/or pharyngeal) as culture confirmed bacterial eradication of N. gonorrhoeae observed 3 to 7 days post-treatment. Pre-treatment urogenital specimens were obtained for nucleic acid amplification test (NAAT) assay to detect the presence of N. gono
Conditions Studied
Interventions
- DRUG GSK2140944
Study Locations (14)
California
- GSK Investigational Site - Fountain Valley
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Palm Springs
- GSK Investigational Site - San Francisco
Other
- GSK Investigational Site - San Juan
- GSK Investigational Site - London
Florida
- GSK Investigational Site - Orlando
Georgia
- GSK Investigational Site - Atlanta
Indiana
- GSK Investigational Site - Indianapolis
Louisiana
- GSK Investigational Site - New Orleans
Nebraska
- GSK Investigational Site - Omaha
Ohio
- GSK Investigational Site - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2015-04-15 |
| Est. Completion | 2016-07-27 |
| Phase | Phase 2 |
What the finished NCT02294682 record still lists
NCT02294682 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 1,435-participant average among 10 other Gonorrhea trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Gonorrhea appearing as the primary indexed condition, and to 1 intervention - of which GSK2140944 is the first listed.
NCT02294682 lists 14 locations in 9 states (California, Other, Florida).
Frequently Asked Questions
What is clinical trial NCT02294682 about?
NCT02294682 is a clinical study titled "A Dose-Ranging Study Evaluating the Efficacy, Safety, and Tolerability of GSK2140944 in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria Gonorrhoeae". GSK2140944 has demonstrated in vitro activity against Neisseria (N.) gonorrhoeae, including ciprofloxacin resistant and susceptible strains. This study is a Phase II, randomized, multicenter, open-label, dose ranging study designed to inform the optimal oral dose of GSK2140944 by further characteriz...
What is the current status of trial NCT02294682?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 106 participants. The study started on 2015-04-15. Estimated completion is 2016-07-27.
What conditions does trial NCT02294682 study?
This clinical trial studies the following conditions: Gonorrhea.
What interventions are being tested in trial NCT02294682?
The interventions under investigation include: GSK2140944 (DRUG).
Who is sponsoring clinical trial NCT02294682?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02294682 being conducted?
This trial has 14 study locations across California, Florida, Georgia, Indiana, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02294682's enrollment target sits among peer trials
106 8th of 10 higher than 3 of 10 other Gonorrhea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gonorrhea trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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