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Oral Omadacycline vs. Oral Nitrofurantoin for the Treatment of Cystitis

NCT03425396 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2020-06-09

Study results available
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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.

Conditions

  • Uncomplicated Urinary Tract Infection
  • Cystitis

Interventions

DRUG

Omadacycline tablets

Oral Omadacycline

DRUG

Nitrofurantoin capsules

Oral Nitrofurantoin

Sponsors & Collaborators

  • Paratek Pharmaceuticals Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-04
Primary Completion
2019-05-15
Completion
2019-06-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03425396 on ClinicalTrials.gov