The Effect of MK0633 in Patients With Chronic Asthma - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00404313

Purpose

A clinical study to evaluate the efficacy and safety of MK0633 in adult patients with chronic asthma.

Condition	Intervention	Phase
Asthma	Drug: MK0633 Drug: Comparator: placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study of MK0633 in Adult Patients With Chronic Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Pulmonary function test data measured over 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall daytime and nighttime symptoms score, beta-agonist use, asthma exacerbations, asthma-specific quality of life questionnaire score, measured over 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment:	688
Study Start Date:	January 2008
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 MK0633 10 mg	Drug: MK0633 Patients will receive 10 mg, 50 mg, or 100 mg MK0633 tablets once daily for 6 weeks. There will be 2 week period during which all patients will receive placebo to MK0633 Other Name: MK0633
Experimental: 2 MK0633 50 mg	Drug: MK0633 Patients will receive 10 mg, 50 mg, or 100 mg MK0633 tablets once daily for 6 weeks. There will be 2 week period during which all patients will receive placebo to MK0633 Other Name: MK0633
Experimental: 3 MK0633 100 mg	Drug: MK0633 Patients will receive 10 mg, 50 mg, or 100 mg MK0633 tablets once daily for 6 weeks. There will be 2 week period during which all patients will receive placebo to MK0633 Other Name: MK0633
Placebo Comparator: 4 placebo	Drug: Comparator: placebo Placebo to MK0633 10 mg, 50 mg, or 100 mg tablets once daily for 6 weeks

Eligibility

Criteria

Inclusion Criteria:

Documented clinical history of symptoms of chronic asthma, including dyspnea, wheezing, chest tightness, cough, and/or sputum production
Males and females 18-70 years of age

Exclusion Criteria:

History of kidney or chronic liver disease
Recent history of heart problems within the past 3 months
Evidence of another clinically significant, active lung disorder such as bronchiectasis or COPD

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404313

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00404313 History of Changes
Other Study ID Numbers:	2006_553, MK0633-007
Study First Received:	November 21, 2006
Last Updated:	May 28, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases

Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012