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| Descriptive Information Fields | |
| Brief Title † | 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 |
| Official Title † | 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. |
| Brief 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. |
| Detailed Description | |
| Study Phase | Phase III |
| Study Type † | Interventional |
| Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment |
| Primary Outcome Measure † | Clinical Response [ Time Frame: 23 days ] [ Designated as safety issue: No ] Bacteriologic Response [ Time Frame: 23 days ] [ Designated as safety issue: No ] |
| Secondary Outcome Measure † | Adverse events assessment [ Time Frame: 42 days with follow-up to a satisfactory conclusion ] [ Designated as safety issue: Yes ] Physical exam; Vital signs; Use of other medications and supplements [ Time Frame: 42 days ] [ Designated as safety issue: Yes ] Laboratory evaluations [ Time Frame: 23 days ] [ Designated as safety issue: Yes ] |
| Condition † | Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB). |
| Intervention † | Drug: clarithromycin extended-release tablets Drug: clarithromycin immediate-release tablets |
| MEDLINE PMIDs | |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | 465 |
| Start Date † | December 2002 |
| Completion Date | |
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
| Gender | Both |
| Ages | 40 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | United States, Canada, Puerto Rico |
| Administrative Information Fields | |
| NCT ID † | NCT00645086 |
| Organization ID | M02-472 |
| Secondary IDs †† | |
| Study Sponsor † | Abbott |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | Abbott |
| Verification Date | March 2008 |
| First Received Date † | March 24, 2008 |
| Last Updated Date | March 26, 2008 |