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

• Sponsor: Advancis Pharmaceutical Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00095368
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Duration (Months): 7
• Patients Per Site Per Month: 71.8

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Pharyngitis; Tonsillitis	Drug: Amoxicillin Pulsatile Release Multiparticulate Tablet (drug)	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• 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 Start Date: Oct 1, 2004
• Study Completion Date: May 1, 2005

Outcome Measures

Primary Outcome Measures

1. Bacteriological outcome at the Test of Cure Visit []

Secondary Outcome Measures

1. Bacteriological outcome at the Late Post Therapy Visit []

2. Clinical Outcome []

3. Safety []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Manford Gooch, MD	Salt Lake City	Utah	United States	84121

Sponsors and Collaborators

• Advancis Pharmaceutical Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00095368
• Other Study ID Numbers: 111.301
• First Posted: Nov 4, 2004
• Last Update Posted: Dec 8, 2006
• Last Verified: Apr 1, 2005

• Keywords provided by , ,: Pharyngitis; Tonsillitis
• Additional relevant MeSH terms: Pharyngitis; Tonsillitis; Amoxicillin

Study Results

No Results Posted as of Dec 8, 2006