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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

Primary Purpose

Pharyngitis, Tonsillitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Amoxicillin Pulsatile Release Multiparticulate Tablet (drug)
Sponsored by
Advancis Pharmaceutical Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pharyngitis focused on measuring Pharyngitis, Tonsillitis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Manford Gooch, MD

Outcomes

Primary Outcome Measures

Bacteriological outcome at the Test of Cure Visit

Secondary Outcome Measures

Bacteriological outcome at the Late Post Therapy Visit
Clinical Outcome
Safety

Full Information

First Posted
November 3, 2004
Last Updated
December 6, 2006
Sponsor
Advancis Pharmaceutical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00095368
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2005
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Advancis Pharmaceutical Corporation

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pharyngitis, Tonsillitis
Keywords
Pharyngitis, Tonsillitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
500 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Amoxicillin Pulsatile Release Multiparticulate Tablet (drug)
Primary Outcome Measure Information:
Title
Bacteriological outcome at the Test of Cure Visit
Secondary Outcome Measure Information:
Title
Bacteriological outcome at the Late Post Therapy Visit
Title
Clinical Outcome
Title
Safety

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Manford Gooch, MD
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States

12. IPD Sharing Statement

Learn more about this 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

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