Not Signed In -
Strep Throat |
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Clinical Trial: APC-231 Once a Day (QD) for 7 days vs. Pencillin taken Four Times a Day (QID) in Pediatric Patients with Strep Throat
This study is currently recruiting patients.
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Purpose
The purpose of this study is to evaluate the efficacy and safety of APC-231 QD for 7 days in the bacteriological outcome at the Test of Cure Visit.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Pharyngitis | Drug: Amoxicillin Pulsatile Release Multiparticluate Sprinkle | Phase III |
MedlinePlus related topics: Streptococcal Infections; Throat Disorders
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase III, Investigator Blind, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of APC-231 Sprinkle QD for 7 days vs Penicillin VK 10 mg/kg QID for 10 days in Pediatric Patients with Streptococcus pyogenes
Secondary Outcomes: Bacteriological outcome at Late Post Therapy Visit; Clinical Outcomes; Safety
Expected Total Enrollment: 500
Study start: December 2004; Expected completion: August 2005
Last follow-up: May 2005; Data entry closure: June 2005
Eligibility
Ages Eligible for Study: 6 Months - 12 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
Exclusion Criteria:
Location and Contact Information
South Carolina
Holston Medical Group, Simpsonville, South Carolina, 29681, United States; Recruiting
Elizabeth Cockrill 423-990-2415
Utah
Institute for Neuroscience Research, Salt Lake City, Utah, 84121, United States; Not yet recruiting
Cheryl Ritchie 801-262-2200 NA
More Information
Record last reviewed: December 2004
Last Updated: December 23, 2004
Record first received: December 23, 2004
ClinicalTrials.gov Identifier: NCT00100126
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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