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OpenTrials
Completed

NCT Number: NCT00095368

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

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).

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Key information

Conditions

Pharyngitis Infections Otorhinolaryngologic Diseases Pharyngeal Diseases Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases Tonsillitis

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Manford Gooch, MD

Salt Lake City, Utah, 84121, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amoxicillin Pulsatile Release Multiparticulate Tablet (drug)

Drug

Primary outcomes

  1. Bacteriological outcome at the Test of Cure Visit

Secondary outcomes

  1. Bacteriological outcome at the Late Post Therapy Visit

  2. Clinical Outcome

  3. Safety

Sponsors and collaborators

Lead sponsor

Advancis Pharmaceutical Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2005
First posted
Nov 4, 2004
Registry last updated
Dec 8, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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