Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma (0476-232)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00943397
First received: July 21, 2009
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

Patients were treated with either montelukast 4 mg oral granules or usual care. Patients who completed Protocol MK0476-176-01 (NCT00943683) had the option to enroll in this study. Additionally, patients with asthma who were 6 to 11 months of age and who had not participated in Protocol MK0476-176-01, could also enroll.


Condition Intervention Phase
Asthma
Drug: montelukast sodium
Drug: Comparator: Usual Care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Controlled, Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Clinical Adverse Experiences (CAEs) Reported by Patients With up to 52 Weeks of Treatment [ Time Frame: Up to 52 weeks of treatment ] [ Designated as safety issue: Yes ]
    An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product


Enrollment: 190
Study Start Date: April 2001
Study Completion Date: June 2003
Primary Completion Date: October 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Montelukast
Drug: montelukast sodium
Montelukast 4 mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks
Other Name: Montelukast
Active Comparator: 2
Usual Care
Drug: Comparator: Usual Care
Usual care defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator's usual clinical practice for 52 weeks

  Eligibility

Ages Eligible for Study:   6 Months to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient successfully completed visit 5 of MK0476 Protocol 176 (NCT00943683)

OR:

  • Patient is in good, stable health
  • Patient has been fed solid foods for at least 1 month
  • Patients had at least 3 episodes of asthma or asthma-like symptoms, all occurring after 8 weeks of age; at least one within 6 months of the Prestudy Visit
  • Patients had to be in need of a controller therapy according to criteria established in the Global Initiative for Asthma (GINA) guidelines

Exclusion Criteria:

  • Patient was hospitalized at the start of the study or had any major surgery 4 weeks prior
  • Patient had an allergy to apples or applesauce
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00943397

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00943397     History of Changes
Other Study ID Numbers: 0476-232, MK0476-232, 2009_619
Study First Received: July 21, 2009
Results First Received: July 27, 2009
Last Updated: May 1, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014