Strep Throat |
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Clinical Trial: 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
This study is no longer recruiting patients.
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Purpose
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).
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Pharyngitis Tonsillitis | Drug: Amoxicillin Pulsatile Release Multiparticulate Tablet (drug) | Phase III |
MedlinePlus related topics: Streptococcal Infections; Throat Disorders; Tonsils/Tonsillectomy
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: 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
Secondary Outcomes: Bacteriological outcome at the Late Post Therapy Visit; Clinical Outcome; Safety
Expected Total Enrollment: 500
Study start: October 2004; Study completion: June 2005
Last follow-up: May 2005; Data entry closure: May 2005
Eligibility
Ages Eligible for Study: 12 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Any serious illness or concomitant condition that the investigator judges will preclude inclusion to the study
- 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
Location Information
Utah
Manford Gooch, MD, Salt Lake City, Utah, 84121, United States
More Information
Record last reviewed: April 2005
Last Updated: April 4, 2005
Record first received: November 3, 2004
ClinicalTrials.gov Identifier: NCT00095368
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
Resources
- Group A Streptococcal Infections (Cleveland Clinic)
- Strep Throat (MayoClinic)

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