Trials / Completed
CompletedNCT04187144
Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in 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
- 1,606 (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 at a unit dose strength of 750mg. Participants will administer two 750 mg tablets, BID. Each dose will be taken with water after consumption of food. |
| DRUG | Placebo matching nitrofurantoin | Placebo matching nitrofurantoin will be available as over-encapsulated unit-dose capsules. Participants will administer 1 capsule BID. Each dose should be taken with water after consumption of food. |
| DRUG | Nitrofurantoin | Nitrofurantoin will be available as over-encapsulated 100 mg capsules containing 25 mg nitrofurantoin macrocrystals and 75 mg nitrofurantoin. Participants will administer one 100 mg capsule, BID. 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. Participants will administer two tablets, BID. Each dose should be taken with water after consumption of food. |
Timeline
- Start date
- 2020-04-23
- Primary completion
- 2022-12-01
- Completion
- 2022-12-01
- First posted
- 2019-12-05
- Last updated
- 2023-07-18
- Results posted
- 2023-07-18
Locations
113 sites across 6 countries: United States, Australia, Bulgaria, India, Poland, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04187144. Inclusion in this directory is not an endorsement.