Oral Omadacycline vs. Oral Nitrofurantoin for the Treatment of Cystitis

Status Completed

Clinical Trial 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.

Clinical Trial Description

Participants were randomized to receive 7 days of treatment of either omadacycline or nitrofurantoin. The End of Treatment visit, Post Therapy Evaluation visit, and Final Follow-up visit was planned within 2 days following the last dose of study drug, on Day 14 (+/- 2 days) after the first dose of study drug, and within 30 to 37 days following the first dose of study drug, respectively. The study followed a double-dummy design. To maintain the study blinding, participants assigned to omadacycline received active omadacycline tablets and over-encapsulated nitrofurantoin placebo tablets. Participants assigned to the nitrofurantoin arm received omadacycline placebo tablets and over-encapsulated active nitrofurantoin capsules. ;

Study Design

Related Conditions & MeSH terms

Cystitis
Uncomplicated Urinary Tract Infection
Urinary Tract Infections

Clinical Trial Details

NCT number	NCT03425396
Study type	Interventional
Source	Paratek Pharmaceuticals Inc
Contact
Status	Completed
Phase	Phase 2
Start date	January 4, 2018
Completion date	June 5, 2019

View Details

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