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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2005-05-31

Brief Summary

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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).

Detailed Description

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Conditions

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Pharyngitis Tonsillitis

Keywords

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Pharyngitis Tonsillitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Amoxicillin Pulsatile Release Multiparticulate Tablet (drug)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Manford Gooch, MD

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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111.301

Identifier Type: -

Identifier Source: org_study_id