MK0524 Asthma POC Study (0524-008)(COMPLETED)

NCT ID: NCT00783601

Last Updated: 2015-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2005-05-31

Brief Summary

The purpose of the study is to demonstrate the benefit of MK0524 compared to placebo in patients with chronic asthma.

Conditions

Asthma

Study Design

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

Study Groups

1

Treatment Sequence 1: MK0524 + placebo, MK0524 + montelukast, placebo, placebo, placebo + montelukast

Group Type: EXPERIMENTAL

Comparator: MK0524 + placebo

Intervention Type: DRUG

Two 150 mg MK0524 tablets + one placebo tablet in the matching image of montelukast 10 mg once daily for 3 weeks

Comparator: MK0524 + montelukast

Intervention Type: DRUG

Two 150 mg MK0524 tablets and one 10 mg montelukast tablet once daily for 2 weeks

Comparator: placebo + montelukast

Intervention Type: DRUG

Two placebo tablets in the matching image of MK0524 150 mg and one 10 mg tablet montelukast once daily for 2 weeks

Comparator: Placebo

Intervention Type: DRUG

During the double-blind treatment periods, patients receive either two placebo tablets in the matching image of MK0524 150 mg or one placebo tablet in the matching image of montelukast 10 mg in a crossover manner. During the washout period before the crossover to the opposite treatment sequence, patients receive two placebo tablets in the matching image of MK0524 150 mg and one placebo tablet in the matching image of montelukast 10 mg once daily for two weeks.

2

Treatment sequence 2: Placebo, montelukast, placebo, MK0524, MK0524 + montelukast

Group Type: EXPERIMENTAL

Comparator: MK0524 + placebo

Intervention Type: DRUG

Two 150 mg MK0524 tablets + one placebo tablet in the matching image of montelukast 10 mg once daily for 3 weeks

Comparator: MK0524 + montelukast

Intervention Type: DRUG

Two 150 mg MK0524 tablets and one 10 mg montelukast tablet once daily for 2 weeks

Comparator: placebo + montelukast

Intervention Type: DRUG

Two placebo tablets in the matching image of MK0524 150 mg and one 10 mg tablet montelukast once daily for 2 weeks

Comparator: Placebo

Intervention Type: DRUG

During the double-blind treatment periods, patients receive either two placebo tablets in the matching image of MK0524 150 mg or one placebo tablet in the matching image of montelukast 10 mg in a crossover manner. During the washout period before the crossover to the opposite treatment sequence, patients receive two placebo tablets in the matching image of MK0524 150 mg and one placebo tablet in the matching image of montelukast 10 mg once daily for two weeks.

Interventions

Comparator: MK0524 + placebo

Two 150 mg MK0524 tablets + one placebo tablet in the matching image of montelukast 10 mg once daily for 3 weeks

Intervention Type: DRUG

Comparator: MK0524 + montelukast

Two 150 mg MK0524 tablets and one 10 mg montelukast tablet once daily for 2 weeks

Intervention Type: DRUG

Comparator: placebo + montelukast

Two placebo tablets in the matching image of MK0524 150 mg and one 10 mg tablet montelukast once daily for 2 weeks

Intervention Type: DRUG

Comparator: Placebo

During the double-blind treatment periods, patients receive either two placebo tablets in the matching image of MK0524 150 mg or one placebo tablet in the matching image of montelukast 10 mg in a crossover manner. During the washout period before the crossover to the opposite treatment sequence, patients receive two placebo tablets in the matching image of MK0524 150 mg and one placebo tablet in the matching image of montelukast 10 mg once daily for two weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Has symptoms of chronic asthma (shortness of breath, wheezing, chest tightness, etc.) for at least 1 year
• Nonsmoker for at least 1 year with a smoking history of no more than 7 pack-years (i.e., 1 pack per day for 7 years)

Exclusion Criteria

• Any clinically significant disease of heart, intestinal, kidney, liver, lung or uncontrolled blood pressure
• Any surgery within 4 weeks prior to Visit 1
• Patient is intending to move or vacation for more than 5 days during the study
• Patient is pregnant or breast-feeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 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

Philip G, van Adelsberg J, Loeys T, Liu N, Wong P, Lai E, Dass SB, Reiss TF. Clinical studies of the DP1 antagonist laropiprant in asthma and allergic rhinitis. J Allergy Clin Immunol. 2009 Nov;124(5):942-8.e1-9. doi: 10.1016/j.jaci.2009.07.006. Epub 2009 Sep 12.

Reference Type: DERIVED

PMID: 19748656 (View on PubMed)

Other Identifiers

MK0524-008

Identifier Type: -

Identifier Source: secondary_id

2007_614

Identifier Type: -

Identifier Source: secondary_id

0524-008

Identifier Type: -

Identifier Source: org_study_id