Oral Omadacycline vs. Oral Nitrofurantoin for the Treatment of Cystitis
NCT ID: NCT03425396
Last Updated: 2020-06-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
225 participants
INTERVENTIONAL
2018-01-04
2019-06-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Omadacycline 300/300 once every 24 hours
Participants received omadacycline 300 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 300 milligrams orally, once every 24 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
Omadacycline tablets
Oral Omadacycline
Omadacycline 450/300 once every 24 hours
Participants received omadacycline 450 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 300 milligrams orally, once every 24 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
Omadacycline tablets
Oral Omadacycline
Omadacycline 450/450 once every 24 hours
Participants received omadacycline 450 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 450 milligrams orally, once every 24 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
Omadacycline tablets
Oral Omadacycline
Omadacycline 450/450 once every 12 hours
Participants received omadacycline 450 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 450 milligrams orally, once every 12 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
Omadacycline tablets
Oral Omadacycline
Nitrofurantoin 100/100 once every 12 hours
Participants received nitrofurantoin 100 milligrams orally, once every 12 hours, fed on Day 1 and nitrofurantoin 100 milligrams orally, once every 12 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
Nitrofurantoin capsules
Oral Nitrofurantoin
Interventions
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Omadacycline tablets
Oral Omadacycline
Nitrofurantoin capsules
Oral Nitrofurantoin
Eligibility Criteria
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Inclusion Criteria
* Must have a qualifying uncomplicated urinary tract infection
* Participants 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
* Evidence of complicated urinary tract infection (UTI), upper UTI, vaginitis, or sexually transmitted infection
* Evidence of significant immunological disease
* Has received an investigational drug within the past 30 days
* Participants who are pregnant or nursing
18 Years
FEMALE
No
Sponsors
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Paratek Pharmaceuticals Inc
INDUSTRY
Responsible Party
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Locations
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Site 106
Chula Vista, California, United States
Site 101
La Mesa, California, United States
Site 109
Los Angeles, California, United States
Site 114
Aventura, Florida, United States
Site 102
DeLand, Florida, United States
Site 103
Hialeah, Florida, United States
Site 125
Jacksonville, Florida, United States
Site 121
Miami, Florida, United States
Site 130
Miami, Florida, United States
Site 115
Miami, Florida, United States
Site 127
Miami Springs, Florida, United States
Site 126
Orlando, Florida, United States
Site 113
Newton, Kansas, United States
Site 110
Wichita, Kansas, United States
Site 112
Omaha, Nebraska, United States
Site 132
Las Vegas, Nevada, United States
Site 108
Las Vegas, Nevada, United States
Site 122
Berlin, New Jersey, United States
Site 118
Raleigh, North Carolina, United States
Site 104
Jackson, Tennessee, United States
Site 105
Smyrna, Tennessee, United States
Site 131
Houston, Texas, United States
Site 120
San Antonio, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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PTK0796-UUTI-17201
Identifier Type: -
Identifier Source: org_study_id
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