NCT00095368CompletedPhase 3
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
Advancis Pharmaceutical Corporation2 sites in 1 country500 target enrollmentStarted: October 1, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 500
- Locations
- 2
- Primary Endpoint
- Bacteriological outcome at the Test of Cure Visit
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Bacteriological outcome at the Test of Cure Visit
Secondary Outcomes
- Bacteriological outcome at the Late Post Therapy Visit
- Clinical Outcome
- Safety
Investigators
Study Sites (2)
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