Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Pfizer |
---|---|
Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00644293 |
To determine if a single 2.0-g dose of azithromycin SR is at least as effective as a 3-day course of azithromycin (500 mg once daily for 3 days) when used to treat adolescents and adults with strep throat, and to assess efficacy and safety for both treatment regimens.
Condition | Intervention | Phase |
---|---|---|
Pharyngitis Tonsillitis |
Drug: azithromycin (Zithromax) Drug: placebo Drug: azithromycin SR |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Three-Day Azithromycin for the Treatment of Group A β-Hemolytic Streptococcal Pharyngitis/Tonsillitis in Adolescents and Adults |
Enrollment: | 598 |
Study Start Date: | January 2003 |
Study Completion Date: | April 2004 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: azithromycin (Zithromax)
azithromycin 500 mg tablet by mouth once daily for 3 days
Drug: placebo
placebo
|
2: Experimental |
Drug: azithromycin SR
azithromycin SR 2.0 g by mouth as an oral slurry for 1 dose
Drug: placebo
placebo
|
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Group ) |
Study ID Numbers: | A0661119 |
Study First Received: | March 19, 2008 |
Last Updated: | March 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00644293 |
Health Authority: | United States: Food and Drug Administration |
Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections Streptococcal Infections Azithromycin |
Tonsillitis Stomatognathic Diseases Pharyngitis Pharyngeal Diseases |
Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses Pharmacologic Actions |