APC-111 MP Tablet Once a Day vs.Penicillin VK Four Times a Day Both for 10 Days in Patients With Strep Throat
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
1 other identifier
interventional
600
2 countries
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2005
Shorter than P25 for phase_3
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2005
CompletedFirst Posted
Study publicly available on registry
October 20, 2005
CompletedStudy Start
First participant enrolled
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedOctober 25, 2006
January 1, 2006
October 18, 2005
October 23, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The bacteriological outcome at the Test - of - Cure Visit (Day 14-18)
Secondary Outcomes (3)
The bacteriological outcome at the Late Post Therapy visit (Day 38-45)
Clinical Outcome at TOC and LPT
Safety
Interventions
Eligibility Criteria
You may qualify if:
- 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
- +3 more criteria
You may not qualify if:
- 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
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Tallassee, Alabama, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Carmichael, California, United States
Unknown Facility
Laguna Niguel, California, United States
Unknown Facility
San Luis Obispo, California, United States
Unknown Facility
Littleton, Colorado, United States
Unknown Facility
DeLand, Florida, United States
Unknown Facility
Conyers, Georgia, United States
Unknown Facility
Boise, Idaho, United States
Unknown Facility
Overland Park, Kansas, United States
Unknown Facility
Topeka, Kansas, United States
Unknown Facility
Wichitia, Kansas, United States
Unknown Facility
Bardstown, Kentucky, United States
Unknown Facility
Milford, Massachusetts, United States
Unknown Facility
New Bedford, Massachusetts, United States
Unknown Facility
Kalamazoo, Michigan, United States
Unknown Facility
Butte, Montana, United States
Unknown Facility
Omaha, Nebraska, United States
Unknown Facility
Johnson City, New York, United States
Unknown Facility
Burlington, North Carolina, United States
Unknown Facility
Simpsonville, North Carolina, United States
Unknown Facility
Canfield, Ohio, United States
Unknown Facility
North Wales, Pennsylvania, United States
Unknown Facility
Scotland, Pennsylvania, United States
Unknown Facility
Shippensburg, Pennsylvania, United States
Unknown Facility
Bristol, Tennessee, United States
Unknown Facility
Kingsport, Tennessee, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Bountiful, Utah, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
West Jordan, Utah, United States
Unknown Facility
Newport News, Virginia, United States
Unknown Facility
Edmonds, Washington, United States
Unknown Facility
Wenatchee, Washington, United States
Unknown Facility
Coquitlam, British Columbia, Canada
Unknown Facility
Fort Erie, Ontario, Canada
Unknown Facility
Markham, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Saint-Jermone, Quebec, Canada
Unknown Facility
Sherbrooke, Quebec, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Susan P Clausen, PhD
Advancis Pharmaceutical Corp
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 18, 2005
First Posted
October 20, 2005
Study Start
November 1, 2005
Study Completion
July 1, 2006
Last Updated
October 25, 2006
Record last verified: 2006-01