NCT00645086

Comparative Study of 5 Days of M02-472 Clarithromycin Extended-Release Tablets to 7 Days of Clarithromycin Immediate-Release Tablets for the Treatment of Exacerbation of Chronic Bronchitis

A Phase III Comparative Efficacy Study of 5 Days of M02-472 Clarithromycin Extended-Release Tablets to 7 Days of Clarithromycin Immediate-Release Tablets for the Treatment of Subjects With Acute Bacterial Exacerbation of Chronic Bronchitis.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 465 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy of a 5-day course of clarithromycin extended-release tablets (2 x 500 mg QD) with that of a 7-day course of clarithromycin immediate-release tablets (1 x 500 mg BID) in the treatment of acute bacterial exacerbation of chronic bronchitis.

Conditions

• Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB).

Interventions

Type	Name	Description
DRUG	clarithromycin extended-release tablets	5-day course of clarithromycin extended-release tablets (2 x 500 mg QD)
DRUG	clarithromycin immediate-release tablets	7-day course of clarithromycin immediate-release tablets (1 x 500 mg BID)

Timeline

• Start date: 2002-12-01
• Primary completion: 2004-04-01
• First posted: 2008-03-27
• Last updated: 2008-03-27

Locations

146 sites across 3 countries: United States, Canada, Puerto Rico