MK0524 Asthma POC Study

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00783601
First received: October 30, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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


Condition Intervention Phase
Asthma
Drug: Comparator: MK0524 + placebo
Drug: Comparator: MK0524 + montelukast
Drug: Comparator: placebo + montelukast
Drug: Comparator: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double Blind, Crossover Study Comparing the Effect of MK0524 With Placebo and Concomitant Administration of MK0524 Plus Montelukast in Adult Patients With Chronic Asthma

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • To demonstrate benefits of MK0524 compared with placebo on Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: Last 2 weeks of each treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the benefits of MK0524 as compared with placebo on the key secondary endpoints (Daytime & Nighttime Asthma Symptoms scores [ Time Frame: Last 2 weeks of each treatment period ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: October 2004
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Treatment Sequence 1: MK0524 + placebo, MK0524 + montelukast, placebo, placebo, placebo + montelukast
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.
Experimental: 2
Treatment sequence 2: Placebo, montelukast, placebo, MK0524, MK0524 + montelukast
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has symptoms of chronic asthma (shortness of breath, wheezing, chest tightness, etc.) for at least 1 year
  • Nonsmoker for at least 1 year with a smoking history of no more than 7 pack-years (i.e., 1 pack per day for 7 years)

Exclusion Criteria:

  • Any clinically significant disease of heart, intestinal, kidney, liver, lung or uncontrolled blood pressure
  • Any surgery within 4 weeks prior to Visit 1
  • Patient is intending to move or vacation for more than 5 days during the study
  • Patient is pregnant or breast-feeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00783601

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00783601     History of Changes
Other Study ID Numbers: 2007_614, MK0524-008
Study First Received: October 30, 2008
Last Updated: October 30, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Chronic Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014