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Sponsored by: |
Advancis Pharmaceutical Corporation |
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Information provided by: | Advancis Pharmaceutical Corporation |
ClinicalTrials.gov Identifier: | NCT00242281 |
The primary objective of this study is to evaluate the efficacy of APC 111 MP Tablet, 775 mg tablet, given orally (PO)once daily (QD) for 10 days compared to that of Penicillin VK, 250 mg PO four times daily (QID) for 10 days in terms of bacteriological outcome at the Test-of-Cure (TOC) Visit (Day 14-18) in the eligible Per-Protocol bacteriological (PPb) population.
Condition | Intervention | Phase |
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Sore Throat Pharyngitis Tonsillitis |
Drug: APC-111 MP Tablet, 775 mg |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Multicenter Study to Evaluate the Safety/Efficacy of APC-111 MP Tablet QD vs. Penicillin VK QID Both for 10 Days Treatment of Pharyngitis Secondary to S.Pyogenes in Adolescents/Adults |
Estimated Enrollment: | 600 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | July 2006 |
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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 and pharyngeal erythema with at least one of the following:
Females must be non-lactating and:
Exclusion Criteria:
Any serious illness or concomitant condition that the Investigator judges would preclude the study evaluations or make it unlikely that the course of study therapy and follow-up could be completed. This would also include:
Concurrent symptoms of viral etiology including:
Study Director: | Susan P Clausen, PhD | Advancis Pharmaceutical Corp |
Study ID Numbers: | 111.302 |
Study First Received: | October 18, 2005 |
Last Updated: | October 23, 2006 |
ClinicalTrials.gov Identifier: | NCT00242281 |
Health Authority: | United States: Food and Drug Administration |
Sore Throat Pharyngitis Tonsillitis |
Penicillin V Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections Streptococcal Infections |
Neoplasm Metastasis Tonsillitis Stomatognathic Diseases Pharyngitis Pharyngeal Diseases |
Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses Pharmacologic Actions |