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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00095368

Enrollment

500

Registered

2004-11-04

Start date

2004-10-31

Completion date

2005-05-31

Last updated

2006-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharyngitis, Tonsillitis

Keywords

Pharyngitis, Tonsillitis

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).

Interventions

DRUGAmoxicillin Pulsatile Release Multiparticulate Tablet (drug)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Bacteriological outcome at the Test of Cure Visit	—

Secondary

Measure	Time frame
Bacteriological outcome at the Late Post Therapy Visit	—
Clinical Outcome	—
Safety	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026