Trials / Completed
CompletedNCT00644293
A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin Sustained Release Versus 3-Day Azithromycin for the Treatment of Strep Throat in Adolescents and Adults
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 598 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 13 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | azithromycin (Zithromax) | azithromycin 500 mg tablet by mouth once daily for 3 days |
| DRUG | placebo | placebo |
| DRUG | azithromycin SR | azithromycin SR 2.0 g by mouth as an oral slurry for 1 dose |
| DRUG | placebo | placebo |
Timeline
- Start date
- 2003-01-01
- Completion
- 2004-04-01
- First posted
- 2008-03-26
- Last updated
- 2011-06-08
Locations
59 sites across 10 countries: United States, Belgium, Finland, France, Germany, India, Italy, Netherlands, Norway, United Kingdom
Source: ClinicalTrials.gov record NCT00644293. Inclusion in this directory is not an endorsement.