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).

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Amoxicillin Pulsatile Release Multiparticulate Tablet (drug)

Primary Measures

• Bacteriological outcome at the Test of Cure Visit

Secondary Measures

• Bacteriological outcome at the Late Post Therapy Visit
• Clinical Outcome
• Safety

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Advancis Pharmaceutical Corporation

Information obtained from ClinicalTrials.gov on November 18, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00095368

Study ID Number: 111.301

ClinicalTrials.gov Identifier: NCT00095368

Health Authority: United States: Food and Drug Administration