NCT00100126

APC-231 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) in Pediatric Patients With Strep Throat

A Phase III, Investigator Blind, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of APC-231 Sprinkle QD for 7 Days vs Penicillin VK 10 mg/kg QID for 10 Days in Pediatric Patients With Streptococcus Pyogenes

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (planned)
• Sponsor: Advancis Pharmaceutical Corporation · Industry
• Sex: All
• Age: 6 Months – 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of APC-231 QD for 7 days in the bacteriological outcome at the Test of Cure Visit.

Conditions

• Pharyngitis

Interventions

Type	Name	Description
DRUG	Amoxicillin Pulsatile Release Multiparticluate Sprinkle

Timeline

• Start date: 2004-12-01
• Completion: 2005-06-01
• First posted: 2004-12-24
• Last updated: 2006-10-25

Locations

2 sites across 1 country: United States