At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 225 enrolled
Drug / intervention
Omadacycline tablets +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blinded, Adaptive Phase 2 Study to Evaluate the Safety and Efficacy of Oral Omadacycline and Oral Nitrofurantoin in the Treatment of Female Adults With Cystitis
In Brief
A Phase 2 clinical trial evaluating Omadacycline tablets and Nitrofurantoin capsules for Uncomplicated Urinary Tract Infection and Cystitis. Completed, enrolled 225 participants across 23 sites.
Detailed Summary
The purpose of this study is to evaluate the safety and efficacy of oral omadacycline as compared to oral nitrofurantoin in the treatment of female adults with cystitis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUncomplicated Urinary Tract Infection, Cystitis
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
Enrollment StartJan 2018
First PostedFeb 2018
Primary CompletionMay 2019
Study CompletionJun 2019
TodayJul 2026
First PostedFeb 7, 2018
Enrollment StartJan 4, 2018
Primary CompletionMay 15, 2019
Study CompletionJun 5, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 8.4 years ago
Interventions
Omadacycline tabletsdrug
Oral Omadacycline
Nitrofurantoin capsulesdrug
Oral Nitrofurantoin