Trials / Completed
CompletedNCT04020341
A Study to Evaluate Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (UTI)
A Phase III, Randomized, Multicenter, Parallel-Group, Double-Blind, Double-Dummy Study in Adolescent and Adult Female Participants Comparing the Efficacy and Safety of Gepotidacin to Nitrofurantoin in the Treatment of Uncomplicated Urinary Tract Infection (Acute Cystitis)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,531 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- Female
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The study will be conducted to evaluate the therapeutic response (combined per participant microbiological and clinical response) of oral gepotidacin compared to oral nitrofurantoin for treatment of uncomplicated UTI (acute cystitis) in adolescent and adult female participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gepotidacin | Gepotidacin will be available as tablets containing 750 mg gepotidacin. Each dose should be taken with water after consumption of food. |
| DRUG | Placebo matching nitrofurantoin | Placebo matching nitrofurantoin will be available as over-encapsulated unit-dose capsules. Each dose should be taken with water after consumption of food. |
| DRUG | Nitrofurantoin | Nitrofurantoin will be available as over-encapsulated capsules containing 25 mg nitrofurantoin macrocrystals and 75 mg nitrofurantoin. Each dose should be taken with water after consumption of food. |
| DRUG | Placebo matching gepotidacin | Placebo matching gepotidacin will be available as unit-dose gepotidacin placebo-to-match tablet. Each dose should be taken with water after consumption of food. |
Timeline
- Start date
- 2019-10-17
- Primary completion
- 2022-11-30
- Completion
- 2022-11-30
- First posted
- 2019-07-16
- Last updated
- 2023-06-22
- Results posted
- 2023-06-22
Locations
103 sites across 12 countries: United States, Bulgaria, Czechia, Germany, Greece, Hungary, India, Mexico, Romania, Slovakia, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04020341. Inclusion in this directory is not an endorsement.