NCT00095368

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (planned)
• Sponsor: Advancis Pharmaceutical Corporation · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Pharyngitis
• Tonsillitis

Interventions

Type	Name	Description
DRUG	Amoxicillin Pulsatile Release Multiparticulate Tablet (drug)

Timeline

• Start date: 2004-10-01
• Completion: 2005-05-01
• First posted: 2004-11-04
• Last updated: 2006-12-08

Locations

1 site across 1 country: United States