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

NCT ID: NCT00404313

Last Updated: 2015-10-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 688 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-06-30

Brief Summary

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

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

MK0633 10 mg

Group Type: EXPERIMENTAL

MK0633

Intervention Type: DRUG

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

MK0633 50 mg

Group Type: EXPERIMENTAL

MK0633

Intervention Type: DRUG

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

MK0633 100 mg

Group Type: EXPERIMENTAL

MK0633

Intervention Type: DRUG

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

Group Type: PLACEBO_COMPARATOR

Comparator: placebo

Intervention Type: DRUG

Placebo to MK0633 10 mg, 50 mg, or 100 mg tablets once daily for 6 weeks

Interventions

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

Intervention Type: DRUG

Comparator: placebo

Placebo to MK0633 10 mg, 50 mg, or 100 mg tablets once daily for 6 weeks

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Wasfi YS, Villaran 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 25.

Reference Type: RESULT

PMID: 21945511 (View on PubMed)

Other Identifiers

MK0633-007

Identifier Type: -

Identifier Source: secondary_id

2006_553

Identifier Type: -

Identifier Source: secondary_id

0633-007

Identifier Type: -

Identifier Source: org_study_id