Back to resultsA Study to Compare Effectiveness of Montelukast Sodium With Comparator in Mild to Moderate Persistent Asthmatics (0476-329)
Primary Purpose
Asthma, Allergic Rhinitis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
MK0476; montelukast sodium/Duration of Treatment: 16 weeks
Comparator: theophylline ER/Duration of Treatment: 16 weeks
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
Inclusion Criteria: Males or females between the ages of 18 and 60 with mild to moderate asthma
Sites / Locations
Outcomes
Primary Outcome Measures
FEV1
Secondary Outcome Measures
AM-PEFR; daytime symptom score; treatment frequency of beta agonist; global assessment investigator's symptom assessment; Quality of Life Questionnaire for Adult Korean Asthmatics; QLQAKA
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00157937
Brief Title
A Study to Compare Effectiveness of Montelukast Sodium With Comparator in Mild to Moderate Persistent Asthmatics (0476-329)
Official Title
A Randomized, Open Label, Cross-Over Study Comparing Effectiveness for the Montelukast Sodium With Comparator in Mild to Moderate Persistent Asthmatics
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
Brief Summary
Subjects have 8-week with montelukast sodium or comparator drug administration period, 2-week wash-out period and 8-week comparator drug or the drug administration period (with cross-over design) for assessment of the drug efficacy, safety and tolerability.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Allergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0476; montelukast sodium/Duration of Treatment: 16 weeks
Intervention Type
Drug
Intervention Name(s)
Comparator: theophylline ER/Duration of Treatment: 16 weeks
Primary Outcome Measure Information:
Title
FEV1
Secondary Outcome Measure Information:
Title
AM-PEFR; daytime symptom score; treatment frequency of beta agonist; global assessment investigator's symptom assessment; Quality of Life Questionnaire for Adult Korean Asthmatics; QLQAKA
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males or females between the ages of 18 and 60 with mild to moderate asthma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
A Study to Compare Effectiveness of Montelukast Sodium With Comparator in Mild to Moderate Persistent Asthmatics (0476-329)
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