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Sponsored by: |
Advancis Pharmaceutical Corporation |
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Information provided by: | Advancis Pharmaceutical Corporation |
ClinicalTrials.gov Identifier: | NCT00100126 |
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 | Intervention | Phase |
---|---|---|
Pharyngitis |
Drug: Amoxicillin Pulsatile Release Multiparticluate Sprinkle |
Phase III |
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 |
Ages Eligible for Study: | 6 Months to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Give informed consent, assent, and documentation of patient authorization for disclosure of study results.
Since all patients are below the legal age of consent, assent from the patient must be obtained (as applicable following state regulations) and written informed consent obtained from the parent or legal guardian.
A clinical diagnosis of acute tonsillitis and/or pharyngitis defined as having the clinical signs and symptoms compatible with tonsillitis and/or pharyngitis, including sore throat or difficulty feeding or swallowing or irritability that suggests the presence of a sore throat with at least one of the following:
Females must be non-lactating and:
Exclusion Criteria:
Chronic or recurrent (two weeks duration two times per year) odynophagia or enlarged tonsils secondary to viral or proven bacterial etiology.
Hard chills or rigors.
United States, South Carolina | |
Simpsonville, South Carolina, United States, 29681 | |
United States, Utah | |
Institute for Neuroscience Research | |
Salt Lake City, Utah, United States, 84121 |
Study Director: | Susan Clausen, PhD | Advancis Pharmaceutical Corp |
Study ID Numbers: | 231.301 |
Study First Received: | December 23, 2004 |
Last Updated: | October 23, 2006 |
ClinicalTrials.gov Identifier: | NCT00100126 |
Health Authority: | United States: Food and Drug Administration |
Pharyngitis Strep throat |
Amoxicillin Penicillin V Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Streptococcal Infections Stomatognathic Diseases Pharyngitis Pharyngeal Diseases |
Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses Pharmacologic Actions |