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

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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.


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
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