Oral Omadacycline vs. Oral Nitrofurantoin for the Treatment of Cystitis
| Status: | Recruiting |
|---|---|
| Conditions: | Urology, Urology |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/4/2019 |
| Start Date: | December 28, 2017 |
| End Date: | July 2019 |
| Contact: | Alissa Sirbu |
| Email: | alissa.sirbu@paratekpharma.com |
| Phone: | 484-751-4926 |
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
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.
compared to oral nitrofurantoin in the treatment of female adults with cystitis.
Inclusion Criteria:
- Female subjects, age 18 or older who have signed the informed consent form
- Must have a qualifying uncomplicated urinary tract infection
- Subjects must not be pregnant at the time of enrollment
- Must agree to a reliable method of birth control during the study and for 30 days
following the last dose of study drug
Exclusion Criteria:
- Males
- Evidence of complicated UTI, upper UTI, vaginitis, or STI
- Evidence of significant immunological disease
- Has received an investigational drug within the past 30 days
- Subjects who are pregnant or nursing
We found this trial at
15
sites
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