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

NCT00644553 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 437

Last updated 2008-03-27

No results posted yet for this study

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

  • Acute Bacterial Sinusitis (ABS)

Interventions

DRUG

Clarithromycin

Clarithromycin Extended-Release 500 mg tablet (2 tablets QD)

DRUG

Amoxicillin

Amoxicillin-clavulanate 875/125 mg tablet (1 tablet BID)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-05-31
Primary Completion
2004-03-31

Countries

  • United States
  • Canada
  • Greece
  • Hungary
  • Italy
  • Lithuania
  • Poland
  • Romania
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00644553 on ClinicalTrials.gov