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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 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.

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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.

Conditions Studied

Gonorrhea

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

1,345 total trials

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What the Registry Record Tells You About NCT02294682

The ClinicalTrials.gov registry entry for NCT02294682 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,435-participant average among 10 other Gonorrhea trials with a reported enrollment target (93% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

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 reports 14 study locations spanning 9 distinct geographic areas - top geographies include 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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.