Intermittent and Daily Dosing for Episodic (Periodic) Asthma
Information source: Merck
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: montelukast sodium (Drug); Comparator: Placebo (unspecified) (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Overall contact:
Toll Free Number, Phone: 1-888-577-8839
Summary
This is a year-long study evaluating the efficacy of both daily and intermittent treatment of
asthma in children who experience symptoms episodically (i. e., seasonally, usually in the
context of upper respiratory tract infection).
Clinical Details
Official title: A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study Evaluating the Effects of 2 Different Regimens of Montelukast (Daily Dosing and Intermittent, Episode-Driven Dosing) Compared With Placebo in the Treatment of Episodic Asthma in Children Aged 6 Months to 5 Years
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Number of asthma episodes culminating in asthma attack over the 1-year treatment period
Secondary outcome: Respiratory symptoms over the 1-year treatment periodsafety and tolerability over the 1-year treatment period
Eligibility
Minimum age: 6 Months.
Maximum age: 5 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients aged 6 Months to 5 years with episodic (periodic) asthma
Exclusion Criteria:
- Patients who are not in otherwise good health
- Patients who have persistent asthma (continual asthma symptoms)
Locations and Contacts
Toll Free Number, Phone: 1-888-577-8839
Merck Sharp & Dohme (Italia) S.P.A., Roma 191, Italy; Recruiting
Gianfranco Botta, Phone: 39 06 36 191187
Merck Sharp & Dohme IDEA, Inc., Moscow 121059, Russian Federation; Recruiting
Tatiana Serebriakova, Phone: 7-495-941-8264
Merck Sharp & Dohme De Mexico, S.A. De C.V., Mexico, D.F. 1090, Mexico; Recruiting
Juan Diaz, Phone: 52-55-5481-9825
Additional Information
(MedWatch - FDA maintained medical product safety Information) (PhRMA Clinical Study Results Database - web-based repository for clinical study results) (Merck: Patient & Caregiver U.S. Product Web Site)
Starting date: August 2006
Last updated: October 29, 2008
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