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clarithromycin immediate-release

Phase 3

Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB). | Small molecule | Infectious Disease |Abbott Laboratories|Last Updated: Mar 27, 2008

Target and mechanism

ModalitySmall molecule

Also known as clarithromycin immediate-release tablets

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment465

FDA Designations

No designations recorded

Clinical trial landscape

clarithromycin immediate-release · 1 trial · 1 indication

Phase 3 1
NCT00645086Comparative 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 BronchitisAcute Bacterial Exacerbation of Chronic Bronchitis (ABECB).
COMPLETED465 Analytics
PHASE3COMPLETED
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
Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB).
NCT00645086465
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Study Endpoints

Primary Endpoints

Clinical Response
23 days
Bacteriologic Response
23 days

Secondary Endpoints

Adverse events assessment
42 days with follow-up to a satisfactory conclusion
Physical exam; Vital signs; Use of other medications and supplements
42 days
Laboratory evaluations
23 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AACTIVE_COMPARATOR -
BACTIVE_COMPARATOR -

Interventions

NameTypeDescription
clarithromycin extended-release tabletsDRUG5-day course of clarithromycin extended-release tablets (2 x 500 mg QD)
clarithromycin immediate-release tabletsDRUG7-day course of clarithromycin immediate-release tablets (1 x 500 mg BID)
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites146

Inclusion Criteria: * Ambulatory subject who does not require intravenous antibiotic therapy. * Subject who has a medical history of chronic bronchitis. * A history of regular medication use (\>=3 consecutive months within the past 2 years) to treat pulmonary disease. * Subject must have evidence o...

Countries:United StatesCanadaPuerto Rico
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