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.

Sponsor:

Information provided by:

Advancis Pharmaceutical Corporation

ClinicalTrials.gov Identifier:

NCT00095368

First received: November 3, 2004

Last updated: December 6, 2006

Last verified: April 2005

History of Changes

Tracking Information
First Received Date ^ICMJE	November 3, 2004
Last Updated Date	December 6, 2006
Start Date ^ICMJE	October 2004
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Bacteriological outcome at the Test of Cure Visit
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00095368 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Bacteriological outcome at the Late Post Therapy Visit Clinical Outcome Safety
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE	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
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).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Pharyngitis Tonsillitis
Intervention ^ICMJE	Drug: Amoxicillin Pulsatile Release Multiparticulate Tablet (drug)
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	500
Completion Date	May 2005
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	12 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00095368
Other Study ID Numbers ^ICMJE	111.301
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Advancis Pharmaceutical Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Advancis Pharmaceutical Corporation
Verification Date	April 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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