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Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Isaac Melamed, M.D., 1st Allergy & Clinical Research Center
ClinicalTrials.gov Identifier:
NCT00557284
First received: November 9, 2007
Last updated: December 5, 2014
Last verified: December 2014

November 9, 2007
December 5, 2014
March 2008
May 2009   (final data collection date for primary outcome measure)
  • Change in Percentage of Body Involvement [ Time Frame: Baseline and 9 weeks ] [ Designated as safety issue: No ]
    Change in percentage of body involvement from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm for AD as measured by study investigator
  • Mean Change in Investigator Global Assessment (IGA) [ Time Frame: Baseline and 9 weeks ] [ Designated as safety issue: No ]
    The mean change in IGA from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm. The IGA is a six-point measure of disease severity and is evaluated by the investigator based on the overall assessment of skin lesions: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5= very severe.
  • Mean Change in PADC (Caregivers Perception of Disease Control) [ Time Frame: Baseline and 9 weeks ] [ Designated as safety issue: No ]
    Mean change in PADC from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm. Caregiver's evaluation of disease control over the previous 7 days and will consist of a four-point scale ranging from complete control (0) to uncontrolled disease (3)
  • Mean Change in Pruritus [ Time Frame: Baseline and 9 weeks ] [ Designated as safety issue: No ]
    Mean change in pruritus scores from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm. Pruritus assessments ("itch") will be recorded for the previous 24 hours using a 4 point-scale, ranging from none (0) to severe (3). Scores are cumulative per week.
  • Mean Change in Weekly Use of Rescue Medication for AD Flare-up - Cetirizine and/or 10% Hydrocortisone Cream [ Time Frame: Baseline and 9 weeks ] [ Designated as safety issue: No ]
    Average of weekly use of cetirizine and/or 10% hydrocortisone cream will be compared for all subjects in each arm from week 1 to week 9. Flare-up is defined as a worsening of the disease that is unacceptable to the participants and leads to second line topical steroid use and/or liquid anti-histamine use. Measurement is noted as 1 for daily use (does not correspond to multiple uses per day).
The change in validated skin assessment scores (EASI) in treating symptoms of atopic dermatitis associated with food allergens [ Time Frame: 9 weeks ]
Complete list of historical versions of study NCT00557284 on ClinicalTrials.gov Archive Site
  • Mean Change in Serum and Urinary Inflammatory Marker Levels [ Time Frame: Baseline and 9 weeks ] [ Designated as safety issue: No ]
    Mean change in levels from baseline to study visit 4 (week 1 compared to week 9)for interleukin 3 (IL3), tumor necrosis factor alpha (TNF alpha), nerve growth factor (NGF), and urinary leukotriene E4 (LTE4)
  • Mean Change in Serum IgE Levels [ Time Frame: Baseline and 9 weeks ] [ Designated as safety issue: No ]
    Mean change in serum levels of IgE from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm.
  • Mean Change in (Gastrointestinal Symptom Rating Scale) GSRS [ Time Frame: Baseline and 9 weeks ] [ Designated as safety issue: No ]
    The mean change from baseline to study visit 4 (week 1 compared to week 9) in GRGS scores (GI symptoms will be recorded on *GSRS validated scale adjusted for pediatrics (*Gastrointestinal Symptoms in Patients with Irritable Bowel Syndrome and Peptic Ulcer Disease) for all subjects in each arm.This scale measures 7 different GI symptoms (1. abdominal pain; 2. nausea and vomiting; 3. abdominal dissention; 4. decreased passage of stools; 5. increased passage of stools; 6. loose stools; 7. hard stools) with severity ranges from 0 - 3 for each point (0 being no complaint and 3 being most severe for a maximum total of 21).
  • The change in serum and urinary inflammatory marker levels [ Time Frame: 9 weeks ]
  • The change in GRSR validated scale for treating gastrointestinal symptoms induced by food allergens [ Time Frame: 9 weeks ]
Not Provided
Not Provided
 
Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Atopic Dermatitis
  • 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, PO QD (given oral daily)
  • Experimental: 1
    Montelukast
    Intervention: Drug: Montelukast
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
May 2009
May 2009   (final data collection date for primary outcome measure)

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 (radioallergosorbent) 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.
Both
1 Year to 8 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00557284
32032
No
Isaac Melamed, M.D., 1st Allergy & Clinical Research Center
1st Allergy & Clinical Research Center
Merck Sharp & Dohme Corp.
Principal Investigator: Isaac R Melamed, MD 1st Allergy & Clinical Research Center
1st Allergy & Clinical Research Center
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP