The Effect of MK0633 in Patients With Chronic Asthma (0633-007)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00404313
First received: November 21, 2006
Last updated: November 19, 2013
Last verified: November 2013
  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 2

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:


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

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: June 2009
Primary Completion Date: June 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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00404313     History of Changes
Other Study ID Numbers: 0633-007, MK0633-007, 2006_553
Study First Received: November 21, 2006
Last Updated: November 19, 2013
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 April 17, 2014