NCT03425396

Oral Omadacycline vs. Oral Nitrofurantoin for the Treatment of Cystitis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: Paratek Pharmaceuticals Inc · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Uncomplicated Urinary Tract Infection
• Cystitis

Interventions

Type	Name	Description
DRUG	Omadacycline tablets	Oral Omadacycline
DRUG	Nitrofurantoin capsules	Oral Nitrofurantoin

Timeline

• Start date: 2018-01-04
• Primary completion: 2019-05-15
• Completion: 2019-06-05
• First posted: 2018-02-07
• Last updated: 2020-06-09
• Results posted: 2020-06-04

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated drug study