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COMPLETED 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

NCT02294682 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 106 participants
Start Date 2015-04-15
Est. Completion 2016-07-27
Phase Phase 2

Sponsor

GlaxoSmithKline

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02294682

The ClinicalTrials.gov registry entry for NCT02294682 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02294682 reports 14 study locations spanning 9 distinct geographic areas — top geographies include California, Other, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02294682?

The interventions under investigation include: GSK2140944 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02294682?

This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial