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clarithromycin immediate-release

Phase 3

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

clarithromycin immediate-release 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

clarithromycin immediate-release clinical trials

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).Unlock trial analytics

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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Frequently asked questions about clarithromycin immediate-release

What is clarithromycin immediate-release?

Clarithromycin immediate-release is a small molecule antibiotic formulation developed by Abbott Laboratories, which trades as ABT. It is used to treat acute bacterial exacerbation of chronic bronchitis, a bacterial infection that worsens breathing in people with chronic bronchitis. The immediate-release tablets are also known as clarithromycin immediate-release tablets.

What is clarithromycin immediate-release used for in acute bacterial exacerbation of chronic bronchitis?

Clarithromycin immediate-release is used to treat acute bacterial exacerbation of chronic bronchitis, a flare-up of bacterial infection in patients with chronic bronchitis. In the clinical program, it was studied in adults aged 40 years and older across the United States, Canada, and Puerto Rico. It is an antibiotic in the infectious disease therapeutic area.

Who makes clarithromycin immediate-release?

Clarithromycin immediate-release is developed by Abbott Laboratories, which is listed under the ticker ABT. Abbott sponsored the clinical trial evaluating the immediate-release tablet formulation in acute bacterial exacerbation of chronic bronchitis.

What phase is clarithromycin immediate-release in?

Clarithromycin immediate-release has been studied in a Phase 3 clinical trial, which is now completed. The program enrolled 465 patients in a randomized, double-blind, active-controlled design. The trial compared five days of clarithromycin extended-release tablets with seven days of clarithromycin immediate-release tablets.

What clinical trials is clarithromycin immediate-release in?

Clarithromycin immediate-release was evaluated in the Phase 3 trial NCT00645086, titled a 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. The trial is completed and enrolled 465 participants across the United States, Canada, and Puerto Rico.

Is clarithromycin immediate-release the same as clarithromycin immediate-release tablets?

Yes. Clarithromycin immediate-release and clarithromycin immediate-release tablets refer to the same product. The immediate-release tablets are the oral formulation studied in the Phase 3 trial for acute bacterial exacerbation of chronic bronchitis, and the two names are used interchangeably for this antibiotic.