APC-111 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) for 10 Days in Patients With Strep Throat
A Phase III, Randomized, Double-Blind, Double-Dummy Multicenter Study to Evaluate the Efficacy and Safety of 775 mg APC-111 MP Tablet QD for 7 Days vs Penicillin VK 250 mg QID for 10 Days in Patients With Streptococcus Pyogenes
1 other identifier
interventional
500
1 country
1
Brief Summary
The purpose of the this study is to evaluate the safety of efficacy of APC-111 775 mg MP tablet once daily dosing for 7 days for treating patients with strep throat. The evaluation will look to confirm if APC-111 eliminates the bacterial infection (Streptococcus pyogenes).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2004
Shorter than P25 for phase_3
1 active site
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
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 3, 2004
CompletedFirst Posted
Study publicly available on registry
November 4, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedDecember 8, 2006
April 1, 2005
November 3, 2004
December 6, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bacteriological outcome at the Test of Cure Visit
Secondary Outcomes (3)
Bacteriological outcome at the Late Post Therapy Visit
Clinical Outcome
Safety
Interventions
Eligibility Criteria
You may qualify if:
- Give informed consent, assent and patient authorization
- Age 12 and over
- A clinical diagnosis of acute pharyngitis or tonsillitis
- A positive rapid Strep test
- Can swallow the oral study dosage forms
- Females must have a negative urine pregnancy test and be using acceptable birth control if sexually active
You may not qualify if:
- Chronic or recurrent odynophagia
- Need for hospitalization or IV antimicrobial therapy
- Pharyngitis known or suspected due to a pathogen resistant to beta-lactam antimicrobials
- Known carrier of S. pyogenes
- Allergies to penicillin or other beta-lactam antibiotics
- Seizure disorder
- Pregnant or nursing
- Expectation of additional systemic antibacterials would be required for another condition
- Current drug or alcohol abuse
- Any experimental drug or device within the last 30 days
- Prior systemic antibiotic therapy within the last 30 days
- Hospitalization within the last month which included antibacterial therapy
- The presence of clinically significant hematologic conditions, etc
- Probenecid treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Manford Gooch, MD
Salt Lake City, Utah, 84121, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
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
November 3, 2004
First Posted
November 4, 2004
Study Start
October 1, 2004
Study Completion
May 1, 2005
Last Updated
December 8, 2006
Record last verified: 2005-04