Pharyngitis Clinical Trial
Official title:
A Phase III, Randomized, Double-Blind, Double-Dummy Multicenter Study to Evaluate the Efficacy and Safety of 775 mg APC-111 MP Tablet QD for 7 Days vs Penicillin VK 250 mg QID for 10 Days in Patients With Streptococcus Pyogenes
The purpose of the this study is to evaluate the safety of efficacy of APC-111 775 mg MP tablet once daily dosing for 7 days for treating patients with strep throat. The evaluation will look to confirm if APC-111 eliminates the bacterial infection (Streptococcus pyogenes).
Status | Completed |
Enrollment | 500 |
Est. completion date | May 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years and older |
Eligibility |
Inclusion Criteria: - Give informed consent, assent and patient authorization - Age 12 and over - A clinical diagnosis of acute pharyngitis or tonsillitis - A positive rapid Strep test - Can swallow the oral study dosage forms - Females must have a negative urine pregnancy test and be using acceptable birth control if sexually active Exclusion Criteria: - Chronic or recurrent odynophagia - Need for hospitalization or IV antimicrobial therapy - Pharyngitis known or suspected due to a pathogen resistant to beta-lactam antimicrobials - Known carrier of S. pyogenes - Allergies to penicillin or other beta-lactam antibiotics - Any serious illness or concomitant condition that the investigator judges will preclude inclusion to the study - Seizure disorder - Pregnant or nursing - Expectation of additional systemic antibacterials would be required for another condition - Current drug or alcohol abuse - Any experimental drug or device within the last 30 days - Prior systemic antibiotic therapy within the last 30 days - Hospitalization within the last month which included antibacterial therapy - The presence of clinically significant hematologic conditions, etc - Probenecid treatment |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Manford Gooch, MD | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Advancis Pharmaceutical Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bacteriological outcome at the Test of Cure Visit | |||
Secondary | Bacteriological outcome at the Late Post Therapy Visit | |||
Secondary | Clinical Outcome | |||
Secondary | Safety |
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