MK0524 Asthma POC Study (0524-008)(COMPLETED)
A Multicenter, Randomized, Double Blind, Crossover Study Comparing the Effect of MK0524 With Placebo and Concomitant Administration of MK0524 Plus Montelukast in Adult Patients With Chronic Asthma
3 other identifiers
interventional
130
0 countries
N/A
Brief Summary
The purpose of the study is to demonstrate the benefit of MK0524 compared to placebo in patients with chronic asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 asthma
Started Oct 2004
Shorter than P25 for phase_2 asthma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 30, 2008
CompletedFirst Posted
Study publicly available on registry
October 31, 2008
CompletedOctober 16, 2015
October 1, 2015
7 months
October 30, 2008
October 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To demonstrate benefits of MK0524 compared with placebo on Forced Expiratory Volume in 1 second (FEV1)
Last 2 weeks of each treatment period
Secondary Outcomes (1)
To determine the benefits of MK0524 as compared with placebo on the key secondary endpoints (Daytime & Nighttime Asthma Symptoms scores
Last 2 weeks of each treatment period
Study Arms (2)
1
EXPERIMENTALTreatment Sequence 1: MK0524 + placebo, MK0524 + montelukast, placebo, placebo, placebo + montelukast
2
EXPERIMENTALTreatment sequence 2: Placebo, montelukast, placebo, MK0524, MK0524 + montelukast
Interventions
Two 150 mg MK0524 tablets + one placebo tablet in the matching image of montelukast 10 mg once daily for 3 weeks
Two 150 mg MK0524 tablets and one 10 mg montelukast tablet once daily for 2 weeks
Two placebo tablets in the matching image of MK0524 150 mg and one 10 mg tablet montelukast once daily for 2 weeks
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 19748656DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2008
First Posted
October 31, 2008
Study Start
October 1, 2004
Primary Completion
May 1, 2005
Study Completion
May 1, 2005
Last Updated
October 16, 2015
Record last verified: 2015-10