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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
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided

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

Keywords provided by Advancis Pharmaceutical Corporation:
Pharyngitis
Tonsillitis

Additional relevant MeSH terms:
Pharyngitis
Tonsillitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
 Otorhinolaryngologic Diseases
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013