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

Sponsored by:	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:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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
1: Experimental 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
2: Experimental 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
3: Experimental 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
4: Placebo Comparator 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:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_553, MK0633-007
Study First Received:	November 21, 2006
Last Updated:	May 28, 2009
ClinicalTrials.gov Identifier:	NCT00404313 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bronchial Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Hypersensitivity
Lung Diseases, Obstructive
Immune System Diseases
Respiratory Tract Diseases
Bronchial Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on September 03, 2009