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
| Sponsors |
Lead Sponsor: Paratek Pharmaceuticals Inc |
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| Source | Paratek Pharmaceuticals Inc | ||||||||||||||||||||||||||
| Brief 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. |
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| 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. |
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| Overall Status | Completed | ||||||||||||||||||||||||||
| Start Date | January 4, 2018 | ||||||||||||||||||||||||||
| Completion Date | June 5, 2019 | ||||||||||||||||||||||||||
| Primary Completion Date | May 15, 2019 | ||||||||||||||||||||||||||
| Phase | Phase 2 | ||||||||||||||||||||||||||
| Study Type | Interventional | ||||||||||||||||||||||||||
| Primary Outcome |
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| Secondary Outcome |
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| Enrollment | 225 | ||||||||||||||||||||||||||
| Condition | |||||||||||||||||||||||||||
| Intervention |
Intervention Type: Drug Intervention Name: Omadacycline tablets Description: Oral Omadacycline Intervention Type: Drug Intervention Name: Nitrofurantoin capsules Description: Oral Nitrofurantoin Arm Group Label: Nitrofurantoin 100/100 once every 12 hours |
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| Eligibility |
Criteria:
Inclusion Criteria: - Female participants, age 18 or older who have signed the informed consent form - 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: - Males - 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 Gender: Female Gender Based: Yes Minimum Age: 18 Years Maximum Age: N/A Healthy Volunteers: No |
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| Location |
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| Location Countries |
United States |
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| Verification Date |
June 2020 |
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| Responsible Party |
Type: Sponsor |
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| Has Expanded Access | No | ||||||||||||||||||||||||||
| Condition Browse | |||||||||||||||||||||||||||
| Number Of Arms | 5 | ||||||||||||||||||||||||||
| Arm Group |
Label: Omadacycline 300/300 once every 24 hours Type: Experimental Description: 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. Label: Omadacycline 450/300 once every 24 hours Type: Experimental Description: 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. Label: Omadacycline 450/450 once every 24 hours Type: Experimental Description: 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. Label: Omadacycline 450/450 once every 12 hours Type: Experimental Description: 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. Label: Nitrofurantoin 100/100 once every 12 hours Type: Active Comparator Description: 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. |
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| Study Design Info |
Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Treatment Masking: Triple (Participant, Investigator, Outcomes Assessor) |
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