drugset / Trial / NCT00644553

Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial Sinusitis

NCT00644553

Phase 3 Completed 437 enrolled Abbott
RandomizedParallel-groupSingle-blindTreatment

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).

Timeline

Start
2003-05
Primary completion
2004-03
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amoxicillin Other / unclassified 875 mg Oral
Comparator Clarithromycin Small molecule 1000 mg Oral
Subject Clavulanate Unknown 125 mg Oral

Indications