APC-111 MP Tablet Once a Day vs.Penicillin VK Four Times a Day Both for 10 Days in Patients With Strep Throat
Information source: Advancis Pharmaceutical Corporation
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sore Throat; Pharyngitis; Tonsillitis
Intervention: APC-111 MP Tablet, 775 mg (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Advancis Pharmaceutical Corporation Official(s) and/or principal investigator(s):
Susan P Clausen, PhD, Study Director, Affiliation: Advancis Pharmaceutical Corp
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The bacteriological outcome at the Test - of - Cure Visit (Day 14-18)
Secondary outcome: The bacteriological outcome at the Late Post Therapy visit (Day 38-45)Clinical Outcome at TOC and LPT Safety
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Birmingham, Alabama, United States
Tallassee, Alabama, United States
Phoenix, Arizona, United States
Coquitlam, British Columbia, Canada
Carmichael, California, United States
San Luis Obispo, California, United States
Laguna Niguel, California, United States
Littleton, Colorado, United States
Deland, Florida, United States
Conyers, Georgia, United States
Boise, Idaho, United States
Wichitia, Kansas, United States
Overland Park, Kansas, United States
Topeka, Kansas, United States
Bardstown, Kentucky, United States
New Bedford, Massachusetts, United States
Milford, Massachusetts, United States
Kalamazoo, Michigan, United States
Butte, Montana, United States
Omaha, Nebraska, United States
Johnson City, New York, United States
Simpsonville, North Carolina, United States
Burlington, North Carolina, United States
Canfield, Ohio, United States
Markham, Ontario, Canada
Toronto, Ontario, Canada
Fort Erie, Ontario, Canada
North Wales, Pennsylvania, United States
Scotland, Pennsylvania, United States
Shippensburg, Pennsylvania, United States
Sherbrooke, Quebec, Canada
Saint-Jermone, Quebec, Canada
Bristol, Tennessee, United States
Kingsport, Tennessee, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
West Jordan, Utah, United States
Bountiful, Utah, United States
Newport News, Virginia, United States
Edmonds, Washington, United States
Wenatchee, Washington, United States
Additional Information
Starting date: November 2005
Ending date: July 2006
Last updated: October 23, 2006
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