NCT00242281

APC-111 MP Tablet Once a Day vs.Penicillin VK Four Times a Day Both for 10 Days in Patients With Strep Throat

A Phase III, Multicenter Study to Evaluate the Safety/Efficacy of APC-111 MP Tablet QD vs. Penicillin VK QID Both for 10 Days Treatment of Pharyngitis Secondary to S.Pyogenes in Adolescents/Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (planned)
• Sponsor: Advancis Pharmaceutical Corporation · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy of APC 111 MP Tablet, 775 mg tablet, given orally (PO)once daily (QD) for 10 days compared to that of Penicillin VK, 250 mg PO four times daily (QID) for 10 days in terms of bacteriological outcome at the Test-of-Cure (TOC) Visit (Day 14-18) in the eligible Per-Protocol bacteriological (PPb) population.

Conditions

• Sore Throat
• Pharyngitis
• Tonsillitis

Interventions

Type	Name	Description
DRUG	APC-111 MP Tablet, 775 mg

Timeline

• Start date: 2005-11-01
• Completion: 2006-07-01
• First posted: 2005-10-20
• Last updated: 2006-10-25

Locations

41 sites across 2 countries: United States, Canada