Trials / Completed
CompletedNCT03354598
Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women
A Prospective Phase 3 Randomized Multi-center Double-blind Study of Efficacy Tolerability & Safety of Oral Sulopenem-etzadroxil/Probenecid vs Ciprofloxacin for Treatment of Uncomplicated Urinary Tract Infections (uUTI) in Adult Women
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,671 (actual)
- Sponsor
- Iterum Therapeutics, International Limited · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability, and safety of oral sulopenem-etzadroxil/probenecid versus oral ciprofloxacin for treatment of uncomplicated urinary tract infection (uUTI) in adult women
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sulopenem-Etzadroxil/Probenecid | Treatment of uncomplicated urinary tract infection |
| DRUG | Ciprofloxacin | Treatment of uncomplicated urinary tract infection |
Timeline
- Start date
- 2018-08-01
- Primary completion
- 2020-01-16
- Completion
- 2020-01-20
- First posted
- 2017-11-28
- Last updated
- 2021-01-12
- Results posted
- 2020-12-17
Locations
60 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03354598. Inclusion in this directory is not an endorsement.