Trials / Completed
CompletedNCT00644553
Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial Sinusitis
A Phase IIIB/IV Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets vs. Amoxicillin-Clavulanate for the Treatment of Subjects With Acute Bacterial Sinusitis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 437 (actual)
- Sponsor
- Abbott · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
To compare the safety/tolerability and efficacy of a 14-day course of clarithromycin extended-release tablets (2 x 500 mg QD) with that of a 14-day course of amoxicillin-clavulanate tablets (875/125 mg BID) for the treatment of ambulatory subjects with Acute Bacterial Sinusitis (ABS).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Clarithromycin | Clarithromycin Extended-Release 500 mg tablet (2 tablets QD) |
| DRUG | Amoxicillin | Amoxicillin-clavulanate 875/125 mg tablet (1 tablet BID) |
Timeline
- Start date
- 2003-05-01
- Primary completion
- 2004-03-01
- First posted
- 2008-03-27
- Last updated
- 2008-03-27
Locations
53 sites across 9 countries: United States, Canada, Greece, Hungary, Italy, Lithuania, Poland, Romania, Spain
Source: ClinicalTrials.gov record NCT00644553. Inclusion in this directory is not an endorsement.