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

This study has been completed.
Sponsor:
Information provided by:
Advancis Pharmaceutical Corporation
ClinicalTrials.gov Identifier:
NCT00242281
First received: October 18, 2005
Last updated: October 23, 2006
Last verified: January 2006
  Purpose

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.


Condition Intervention Phase
Sore Throat
Pharyngitis
Tonsillitis
Drug: APC-111 MP Tablet, 775 mg
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, 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

Resource links provided by NLM:


Further study details as provided by Advancis Pharmaceutical Corporation:

Primary Outcome Measures:
  • The bacteriological outcome at the Test - of - Cure Visit (Day 14-18)

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

Estimated Enrollment: 600
Study Start Date: November 2005
Estimated Study Completion Date: July 2006
  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00242281

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

No publications provided

ClinicalTrials.gov Identifier: NCT00242281     History of Changes
Other Study ID Numbers: 111.302
Study First Received: October 18, 2005
Last Updated: October 23, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Advancis Pharmaceutical Corporation:
Sore Throat
Pharyngitis
Tonsillitis

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

ClinicalTrials.gov processed this record on August 28, 2014