The primary objective of this study is to evaluate the efficacy of APC 111 MP Tablet, 775 mg tablet, given orally (PO)once daily (QD) for 10 days compared to that of Penicillin VK, 250 mg PO four times daily (QID) for 10 days in terms of bacteriological outcome at the Test-of-Cure (TOC) Visit (Day 14-18) in the eligible Per-Protocol bacteriological (PPb) population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
600
The bacteriological outcome at the Test - of - Cure Visit (Day 14-18)
The bacteriological outcome at the Late Post Therapy visit (Day 38-45)
Clinical Outcome at TOC and LPT
Safety
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Birmingham, Alabama, United States
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Tallassee, Alabama, United States
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Phoenix, Arizona, United States
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Carmichael, California, United States
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Laguna Niguel, California, United States
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San Luis Obispo, California, United States
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Littleton, Colorado, United States
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DeLand, Florida, United States
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Conyers, Georgia, United States
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Boise, Idaho, United States
...and 31 more locations