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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Tonsillitis
Pharyngitis
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 July 20, 2014