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

Primary Purpose

Sore Throat, Pharyngitis, Tonsillitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
APC-111 MP Tablet, 775 mg
Sponsored by
Advancis Pharmaceutical Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sore Throat focused on measuring Sore Throat, Pharyngitis, Tonsillitis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

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

Full Information

First Posted
October 18, 2005
Last Updated
October 23, 2006
Sponsor
Advancis Pharmaceutical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00242281
Brief Title
APC-111 MP Tablet Once a Day vs.Penicillin VK Four Times a Day Both for 10 Days in Patients With Strep Throat
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 Type
Interventional

2. Study Status

Record Verification Date
January 2006
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Advancis Pharmaceutical Corporation

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sore Throat, Pharyngitis, Tonsillitis
Keywords
Sore Throat, Pharyngitis, Tonsillitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
600 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
APC-111 MP Tablet, 775 mg
Primary Outcome Measure Information:
Title
The bacteriological outcome at the Test - of - Cure Visit (Day 14-18)
Secondary Outcome Measure Information:
Title
The bacteriological outcome at the Late Post Therapy visit (Day 38-45)
Title
Clinical Outcome at TOC and LPT
Title
Safety

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan P Clausen, PhD
Organizational Affiliation
Advancis Pharmaceutical Corp
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
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United States
City
Tallassee
State/Province
Alabama
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United States
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Phoenix
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Arizona
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Carmichael
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California
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United States
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Laguna Niguel
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California
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United States
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San Luis Obispo
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California
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Littleton
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Colorado
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Deland
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Conyers
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Georgia
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Boise
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Idaho
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Overland Park
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Topeka
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Kansas
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Wichitia
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Bardstown
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Kentucky
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Milford
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Massachusetts
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New Bedford
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Massachusetts
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Kalamazoo
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Michigan
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Butte
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Montana
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Omaha
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Nebraska
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Johnson City
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New York
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Burlington
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North Carolina
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Simpsonville
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North Carolina
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Canfield
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Ohio
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North Wales
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Pennsylvania
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Scotland
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Shippensburg
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Bristol
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Tennessee
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Kingsport
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Tennessee
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San Antonio
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Texas
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Bountiful
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Utah
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Salt Lake City
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Utah
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West Jordan
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Newport News
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Virginia
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Edmonds
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Washington
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Wenatchee
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Washington
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Coquitlam
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British Columbia
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Canada
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Fort Erie
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Ontario
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Canada
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Markham
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Ontario
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Canada
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Toronto
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Ontario
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Canada
City
Saint-Jermone
State/Province
Quebec
Country
Canada
City
Sherbrooke
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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