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MK0524 Asthma POC Study (0524-008)(COMPLETED)

NCT00783601 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2015-10-16

No results posted yet for this study

Summary

The purpose of the study is to demonstrate the benefit of MK0524 compared to placebo in patients with chronic asthma.

Conditions

Interventions

DRUG

Comparator: MK0524 + placebo

Two 150 mg MK0524 tablets + one placebo tablet in the matching image of montelukast 10 mg once daily for 3 weeks

DRUG

Comparator: MK0524 + montelukast

Two 150 mg MK0524 tablets and one 10 mg montelukast tablet once daily for 2 weeks

DRUG

Comparator: placebo + montelukast

Two placebo tablets in the matching image of MK0524 150 mg and one 10 mg tablet montelukast once daily for 2 weeks

DRUG

Comparator: Placebo

During the double-blind treatment periods, patients receive either two placebo tablets in the matching image of MK0524 150 mg or one placebo tablet in the matching image of montelukast 10 mg in a crossover manner. During the washout period before the crossover to the opposite treatment sequence, patients receive two placebo tablets in the matching image of MK0524 150 mg and one placebo tablet in the matching image of montelukast 10 mg once daily for two weeks.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2005-05-31
Completion
2005-05-31

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Entities

Diseases
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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 NCT00783601 on ClinicalTrials.gov