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

Pharyngitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00095368
• Other study ID #: 111.301
• Status: Completed
• Phase: Phase 3
• First received: November 3, 2004
• Last updated: December 6, 2006
• Start date: October 2004
• Est. completion date: May 2005

Study information

• Verified date: April 2005
• Source: Advancis Pharmaceutical Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Pharyngitis
• Tonsillitis

Intervention

Drug:
• Amoxicillin Pulsatile Release Multiparticulate Tablet (drug)

Locations

Country	Name	City	State
United States	Manford Gooch, MD	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Advancis Pharmaceutical Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacteriological outcome at the Test of Cure Visit
Secondary	Bacteriological outcome at the Late Post Therapy Visit
Secondary	Clinical Outcome
Secondary	Safety