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

Asthma Clinical Trial

Official title:

A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study of MK0633 in Adult Patients With Chronic Asthma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00404313
• Other study ID #: 0633-007
• Secondary ID: MK0633-0072006_5
• Status: Terminated
• Phase: Phase 2
• First received: November 21, 2006
• Last updated: October 19, 2015
• Start date: January 2008
• Est. completion date: June 2009

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 688
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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
• Comparator: placebo
Placebo to MK0633 10 mg, 50 mg, or 100 mg tablets once daily for 6 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Wasfi YS, Villarán C, de Tilleghem Cle B, Smugar SS, Hanley WD, Reiss TF, Knorr BA. The efficacy and tolerability of MK-0633, a 5-lipoxygenase inhibitor, in chronic asthma. Respir Med. 2012 Jan;106(1):34-46. doi: 10.1016/j.rmed.2011.08.019. Epub 2011 Sep — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary function test data measured over 6 weeks		6 weeks	No
Secondary	Overall daytime and nighttime symptoms score, beta-agonist use, asthma exacerbations, asthma-specific quality of life questionnaire score, measured over 6 weeks		6 weeks	No