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NCT00157937 Clinical Trial

A Study to Compare Effectiveness of Montelukast Sodium With Comparator in Mild to Moderate Persistent Asthmatics (0476-329)

Asthma Clinical Trial

Official title:
A Randomized, Open Label, Cross-Over Study Comparing Effectiveness for the Montelukast Sodium With Comparator in Mild to Moderate Persistent Asthmatics

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00157937
Other study ID # 0476-329
Secondary ID 2005_069
Status Completed
Phase Phase 4
First received
Last updated
Start date February 2003
Est. completion date June 2005

Study information
Verified date January 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date June 2005
Est. primary completion date June 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Males or females between the ages of 18 and 60 with mild to moderate asthma

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0476; montelukast sodium/Duration of Treatment: 16 weeks

• Comparator: theophylline ER/Duration of Treatment: 16 weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

Outcome
Type Measure Description Time frame Safety issue
Primary FEV1
Secondary 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
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