APC-111 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) for 10 Days in Patients With Strep Throat

Condition(s) targeted: Pharyngitis; Tonsillitis

Intervention: Amoxicillin Pulsatile Release Multiparticulate Tablet (drug) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Advancis Pharmaceutical Corporation

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).

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Bacteriological outcome at the Test of Cure Visit

Secondary outcome:

Bacteriological outcome at the Late Post Therapy Visit

Clinical Outcome

Safety

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Manford Gooch, MD, Salt Lake City, Utah 84121, United States

Starting date: October 2004
Last updated: December 6, 2006