APC-111 MP Tablet Once a Day vs.Penicillin VK Four Times a Day Both for 10 Days in Patients With Strep Throat

October 23, 2006 updated by: Advancis Pharmaceutical Corporation

A Phase III, Multicenter Study to Evaluate the Safety/Efficacy of APC-111 MP Tablet QD vs. Penicillin VK QID Both for 10 Days Treatment of Pharyngitis Secondary to S.Pyogenes in Adolescents/Adults

The primary objective of this study is to evaluate the efficacy of APC 111 MP Tablet, 775 mg tablet, given orally (PO)once daily (QD) for 10 days compared to that of Penicillin VK, 250 mg PO four times daily (QID) for 10 days in terms of bacteriological outcome at the Test-of-Cure (TOC) Visit (Day 14-18) in the eligible Per-Protocol bacteriological (PPb) population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Coquitlam, British Columbia, Canada
    • Ontario
      • Fort Erie, Ontario, Canada
      • Markham, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Saint-Jermone, Quebec, Canada
      • Sherbrooke, Quebec, Canada
  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Tallassee, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
    • California
      • Carmichael, California, United States
      • Laguna Niguel, California, United States
      • San Luis Obispo, California, United States
    • Colorado
      • Littleton, Colorado, United States
    • Florida
      • Deland, Florida, United States
    • Georgia
      • Conyers, Georgia, United States
    • Idaho
      • Boise, Idaho, United States
    • Kansas
      • Overland Park, Kansas, United States
      • Topeka, Kansas, United States
      • Wichitia, Kansas, United States
    • Kentucky
      • Bardstown, Kentucky, United States
    • Massachusetts
      • Milford, Massachusetts, United States
      • New Bedford, Massachusetts, United States
    • Michigan
      • Kalamazoo, Michigan, United States
    • Montana
      • Butte, Montana, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New York
      • Johnson City, New York, United States
    • North Carolina
      • Burlington, North Carolina, United States
      • Simpsonville, North Carolina, United States
    • Ohio
      • Canfield, Ohio, United States
    • Pennsylvania
      • North Wales, Pennsylvania, United States
      • Scotland, Pennsylvania, United States
      • Shippensburg, Pennsylvania, United States
    • Tennessee
      • Bristol, Tennessee, United States
      • Kingsport, Tennessee, United States
    • Texas
      • San Antonio, Texas, United States
    • Utah
      • Bountiful, Utah, United States
      • Salt Lake City, Utah, United States
      • West Jordan, Utah, United States
    • Virginia
      • Newport News, Virginia, United States
    • Washington
      • Edmonds, Washington, United States
      • Wenatchee, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent/assent
  • Age 12 and older

  • A clinical diagnosis of acute tonsillitis and/or pharyngitis defined as having the clinical signs and symptoms compatible with tonsillitis and/or pharyngitis, including sore throat and pharyngeal erythema with at least one of the following:

    • Odynophagia
    • Tonsillar or pharyngeal exudates
    • Tender cervical lymph nodes
    • Fever or history of fever treated with antipyretics
    • Chills
    • Uvular edema
    • Elevated white blood cell count
    • Red tongue and prominent papillae
  • A positive rapid screening test for S. pyogenes
  • Subject is an appropriate candidate for oral antibiotic therapy and can swallow the study dosage forms

  • Females must be non-lactating and:

    • At no risk of pregnancy for one of the following reasons: post-menopausal for at least one year, hysterectomy, tubal ligation, or abstinent from sexual activity that could result in pregnancy, OR
    • If of child-bearing potential and sexually active, the patient must have a negative baseline urine pregnancy test and be utilizing acceptable contraceptives throughout the study.
    • If of child bearing potential and not currently sexually active, the patient must have a negative baseline urine pregnancy test and must agree to remain abstinent for the duration of the study. If they decide to become sexually active during the period of the study, they must agree to use acceptable contraception.
  • Are able to comply with the requirements of the protocol

Exclusion Criteria:

  • Chronic or recurrent odynophagia or enlarged tonsils of obscure etiology
  • More than one episode of acute tonsillitis and/or pharyngitis in the 6 months prior to baseline visit
  • Pharyngitis known or suspected to be due to a pathogen resistant to β-lactam antimicrobials
  • Subjects who are known carriers of S. pyogenes
  • Previous allergies, serious adverse reaction to, or intolerance to penicillin or any other member of the β-lactam class of antimicrobials, including cephalosporins

  • Any serious illness or concomitant condition that the Investigator judges would preclude the study evaluations or make it unlikely that the course of study therapy and follow-up could be completed. This would also include:

    • Any rapidly progressive underlying disease with a shortened life expectancy
    • The inability to swallow the study dosage form
    • Unable to understand the requirements of the study
    • Neutropenia (<1000 PMNs/mm3) or other immunocompromised state.
  • Concurrent condition of upper/lower respiratory tract infections

  • Concurrent symptoms of viral etiology including:

    • conjunctivitis, coryza, and cough
    • diffuse adenopathy or rash suggestive of mononucleosis
    • rash or arthropathy suggestive of scarlet fever
  • Seizure disorder, lowered seizure threshold, or psychiatric condition requiring use of major tranquilizers
  • Pregnancy or nursing
  • Expectation that additional effective systemic antibacterials would be required for any condition during the duration of the study
  • Current drug or alcohol abuse
  • Receipt of any experimental drug or medical device within the previous 30 days
  • Previous treatment under this protocol
  • The need for hospitalization or I.V. antimicrobial therapy
  • Previous systemic antimicrobial therapy within 30 days
  • The presence of clinically significant hematologic conditions
  • History of cardiovascular disease, renal disease, or neurological disease secondary to previous infection with S. pyogenes or previous rheumatic fever
  • Probenecid treatment or systemic steroids for 7 days prior to baseline visit and throughout the duration of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The bacteriological outcome at the Test - of - Cure Visit (Day 14-18)

Secondary Outcome Measures

Outcome Measure
Safety
The bacteriological outcome at the Late Post Therapy visit (Day 38-45)
Clinical Outcome at TOC and LPT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advancis Pharmaceutical Corporation

Investigators

  • Study Director: Susan P Clausen, PhD, Advancis Pharmaceutical Corp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Study Completion

July 1, 2006

Study Registration Dates

First Submitted

October 18, 2005

First Submitted That Met QC Criteria

October 18, 2005

First Posted (Estimate)

October 20, 2005

Study Record Updates

Last Update Posted (Estimate)

October 25, 2006

Last Update Submitted That Met QC Criteria

October 23, 2006

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111.302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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