NCT00157937

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma
• Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	MK0476; montelukast sodium/Duration of Treatment: 16 weeks
DRUG	Comparator: theophylline ER/Duration of Treatment: 16 weeks

Timeline

• Start date: 2003-02-01
• Primary completion: 2005-06-01
• Completion: 2005-06-01
• First posted: 2005-09-12
• Last updated: 2024-08-15