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

November 3, 2004
December 6, 2006
October 2004
Not Provided
Bacteriological outcome at the Test of Cure Visit
Same as current
Complete list of historical versions of study NCT00095368 on ClinicalTrials.gov Archive Site
  • Bacteriological outcome at the Late Post Therapy Visit
  • Clinical Outcome
  • Safety
Same as current
Not Provided
Not Provided
 
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
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

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Pharyngitis
  • Tonsillitis
Drug: Amoxicillin Pulsatile Release Multiparticulate Tablet (drug)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
May 2005
Not Provided

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00095368
111.301
Not Provided
Not Provided
Advancis Pharmaceutical Corporation
Not Provided
Not Provided
Advancis Pharmaceutical Corporation
April 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP