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Antibacterial
Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI)
Phase 3
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (on or before day 1), on-therapy (days 2 to 5), and test of cure (days 9 to 16)
Awards & highlights
Pivotal Trial
Summary
This trial compares two pills, gepotidacin and nitrofurantoin, to see which is better for treating UTIs in adolescent and adult women. Both aim to kill the bacteria causing the infection but use different methods. Nitrofurantoin has been used for a long time for the treatment of urinary tract infections (UTIs).
Eligible Conditions
- Urinary Tract Infection
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (on or before day 1), on-therapy (days 2 to 5), and test of cure (days 9 to 16)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (on or before day 1), on-therapy (days 2 to 5), and test of cure (days 9 to 16)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S (IA Set)
Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S Population
Secondary study objectives
Absolute Mean Values of Urine Potential of Hydrogen (pH)
Absolute Mean Values of Urine Specific Gravity
Change From Baseline in Body Temperature
+30 moreSide effects data
From 2023 Phase 3 trial • 628 Patients • NCT0401053949%
Diarrhoea
24%
Nausea
6%
Vomiting
6%
Flatulence
5%
Abdominal Pain
5%
Faeces soft
5%
Dizziness
4%
Chlamydial infection
3%
Headache
3%
Fatigue
2%
Abdominal distension
2%
Abdominal pain upper
2%
Urethritis chlamydial
2%
Hyperhidrosis
2%
Vision blurred
1%
Abdominal discomfort
1%
Proctitis chlamydial
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gepotidacin
Ceftriaxone Plus Azithromycin
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: GepotidacinExperimental Treatment2 Interventions
Participants will be administered oral doses of 1500 milligrams (mg) gepotidacin plus nitrofurantoin matching placebo BID; approximately every 12 hours for 5 days.
Group II: NitrofurantoinActive Control2 Interventions
Participants will be administered oral doses of 100 mg nitrofurantoin plus gepotidacin matching placebo BID; approximately every 12 hours for 5 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gepotidacin
2020
Completed Phase 3
~4410
Placebo matching nitrofurantoin
2020
Completed Phase 3
~3140
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,812 Previous Clinical Trials
8,380,642 Total Patients Enrolled
1 Trials studying Urinary Tract Infection
2,648 Patients Enrolled for Urinary Tract Infection
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,605 Previous Clinical Trials
6,143,465 Total Patients Enrolled