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

This study has been completed.

Sponsored by:	Advancis Pharmaceutical Corporation
Information provided by:	Advancis Pharmaceutical Corporation
ClinicalTrials.gov Identifier:	NCT00095368

Purpose

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	Intervention	Phase
Pharyngitis Tonsillitis	Drug: Amoxicillin Pulsatile Release Multiparticulate Tablet (drug)	Phase III

MedlinePlus related topics: Sore Throat Streptococcal Infections Tonsils and Adenoids

Drug Information available for: Amoxicillin Amoxicillin sodium Amoxicillin trihydrate Penicillins Penicillin V Penicillin V Potassium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Advancis Pharmaceutical Corporation:

Primary Outcome Measures:

Bacteriological outcome at the Test of Cure Visit

Secondary Outcome Measures:

Bacteriological outcome at the Late Post Therapy Visit
Clinical Outcome
Safety

Estimated Enrollment:	500
Study Start Date:	October 2004
Estimated Study Completion Date:	May 2005

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00095368

Locations

United States, Utah
Manford Gooch, MD
Salt Lake City, Utah, United States, 84121

Sponsors and Collaborators

Advancis Pharmaceutical Corporation

More Information

Study ID Numbers:	111.301
Study First Received:	November 3, 2004
Last Updated:	December 6, 2006
ClinicalTrials.gov Identifier:	NCT00095368
Health Authority:	United States: Food and Drug Administration

Keywords provided by Advancis Pharmaceutical Corporation:

Pharyngitis
Tonsillitis

Study placed in the following topic categories:

Amoxicillin
Penicillin V
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Streptococcal Infections
Tonsillitis
Stomatognathic Diseases
Pharyngitis
Pharyngeal Diseases

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009