Study of GSK2140944 in Uncomplicated Urogenital Gonorrhea
Research type
Research Study
Full title
A Phase II, Randomized, Multicenter, Dose-Ranging Study in Adult Subjects Evaluating the Efficacy, Safety, and Tolerability of Single Doses of GSK2140944 in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria gonorrhoeae
IRAS ID
198775
Contact name
Syed Tariq Sadiq
Contact email
Sponsor organisation
GlaxoSmithKline
Eudract number
2015-005120-26
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
111885, IND
Duration of Study in the UK
0 years, 5 months, 30 days
Research summary
Gonorrhoea is the second most common bacterial sexually transmitted infection globally. Infections with the bacteria Neisseria gonorrhoeae can involve cervicitis, proctitis, urethritis, pelvic inflammatory disease and pharyngitis. Complications can include infertility, ectopic pregnancy, chronic pelvic pain, adverse outcomes of pregnancy and increased susceptibility to and transmission of human immunodeficiency virus. The infection is an important clinical and public health issue.
Various antimicrobial treatments are available including a combination therapy with a single intramuscular dose of ceftriaxone plus either a single dose of azithromycin or a 7 days regimen of doxycycline. The effectiveness of the treatments however, has decreased rapidly due to the bacteria Neisseria gonorrhoeae developing resistance to the available antibmicrobials. This issue has complicated the management of the disease and there is currently an urgent requirement for new & effective treatments.
The purpose of this study is to demonstrate the effectiveness of single oral doses of gepotidacin to treat adult participants with uncomplicated urogenital gonorrhoea caused by Neisseria gonorrhoeae and to evaluate the safety and tolerability of single oral doses of gepotidacin in participants with gonorrhoea.
Approximately 90 people will take part in the study with about 40 being from the UK. The expected patient participation in the study will last around 4 to 8 days. Participants will require attending the hospital clinic on 2 occasions. A Day 1 visit and then they will then return at Day 4 to 8 for a test of cure visit.
Participants will be randomised to receive a single 1500mg or 3000mg oral dose of study drug.REC name
London - Fulham Research Ethics Committee
REC reference
16/LO/0439
Date of REC Opinion
21 Apr 2016
REC opinion
Further Information Favourable Opinion