Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens | RxWiki

Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens

Overview[ - collapse ][ - ]

Purpose	AD is a disease found in children; the focus of the study is the mechanisms associated in children with AD induced by food allergies. This study will be a randomized, double-blind, placebo-controlled, parallel group trial conducted in participants diagnosed with atopic dermatitis and food allergies. The study duration for participants will be approximately 9 weeks. A total of 20 participants will be recruited for the entire study. Each arm will consist of 10 participants.The study will enroll 20 children, male or female, 1 - 8 years of age with atopic dermatitis (AD) associated with food allergens, previously documented by skin or RAST test, before enrollment. Atopic dermatitis and gastrointestinal (GI) symptoms will be scored and followed throughout the study.
Condition	Atopic Dermatitis
Intervention	Drug: Montelukast Drug: Placebo
Phase	Phase 4
Sponsor	1st Allergy & Clinical Research Center
Responsible Party	1st Allergy & Clinical Research Center
ClinicalTrials.gov Identifier	NCT00557284
First Received	November 9, 2007
Last Updated	January 25, 2012
Last verified	January 2012

Tracking Information[ + expand ][ + ]

First Received Date	November 9, 2007
Last Updated Date	January 25, 2012
Start Date	March 2008
Estimated Primary Completion Date	May 2009
Current Primary Outcome Measures	The change in validated skin assessment scores (EASI) in treating symptoms of atopic dermatitis associated with food allergens [Time Frame: 9 weeks] [Designated as safety issue: No]
Current Secondary Outcome Measures	The change in serum and urinary inflammatory marker levels [Time Frame: 9 weeks] [Designated as safety issue: No] The change in GSRS validated scale for treating gastrointestinal symptoms induced by food allergens [Time Frame: 9 weeks] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens
Official Title	A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Montelukast (Singulair) in Participants Ages 1 - 8 Years Diagnosed With Atopic Dermatitis Induced by Food Allergens
Brief Summary	AD is a disease found in children; the focus of the study is the mechanisms associated in children with AD induced by food allergies. This study will be a randomized, double-blind, placebo-controlled, parallel group trial conducted in participants diagnosed with atopic dermatitis and food allergies. The study duration for participants will be approximately 9 weeks. A total of 20 participants will be recruited for the entire study. Each arm will consist of 10 participants.The study will enroll 20 children, male or female, 1 - 8 years of age with atopic dermatitis (AD) associated with food allergens, previously documented by skin or RAST test, before enrollment. Atopic dermatitis and gastrointestinal (GI) symptoms will be scored and followed throughout the study.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Condition	Atopic Dermatitis
Intervention	Drug: Montelukast 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age Drug: Placebo Oral granules or chewable tablet, POQD
Study Arm (s)	Experimental: 1 Placebo Comparator: 2

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	20
Estimated Completion Date	May 2009
Estimated Primary Completion Date	May 2009
Eligibility Criteria	Inclusion Criteria: 1. Mild to moderate atopic dermatitis involving greater than or equal to 5% of body surface 2. Total severity score of 2 or greater for any 3 of the 4 signs and symptoms calculated by study doctor (erythema, papulation, or lichenification) 3. Positive skin or RAST tests by ImmunoCap to food or environmental allergens 4. GI symptoms total score of 2 by caregiver on GSRS scale revised for pediatrics Exclusion Criteria: 1. Participants with intolerance or allergy to montelukast. 2. History of anaphylaxis requiring hospitalization. 3. No underlying renal or liver disease. 4. Participants with a diagnosis of severe asthma. 5. Participants diagnosed with primary immune deficiency. 6. Participants using sublingual immunotherapy. 7. Immunotherapy must be a maintenance dose for a minimum of 30 days. 8. If on gastrointestinal medication, 30 day stable dose before visit 1 and maintained throughout the study.
Gender	Both
Ages	1 Year
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00557284
Other Study ID Numbers	32032
Has Data Monitoring Committee	No
Information Provided By	1st Allergy & Clinical Research Center
Study Sponsor	1st Allergy & Clinical Research Center
Collaborators	Merck Sharp & Dohme Corp.
Investigators	Principal Investigator: Isaac R Melamed, MD 1st Allergy & Clinical Research Center
Verification Date	January 2012

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