Study of the Efficacy and Safety of MK-0476 in Japanese Pediatric Participants With Seasonal Allergic Rhinitis (MK-0476-519 AM1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01857063
First received: May 16, 2013
Last updated: September 16, 2013
Last verified: September 2013
  Purpose

This study will evaluate the efficacy and safety of MK-0476 in the treatment of Japanese pediatric participants with seasonal allergic rhinitis (SAR).


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: MK-0476
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Double-Blind, Randomized, Placebo-Controlled Cross-over Clinical Trial to Study the Efficacy and Safety of MK-0476 in Japanese Pediatric Subjects With Seasonal Allergic Rhinitis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change from Baseline in Total Nasal Symptom Score (TNSS) Averaged During 3 Hours of Exposure [ Time Frame: Baseline and Day 7 ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Experience at Least One Adverse Event [ Time Frame: Up to 14 days after last dose of study drug ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from Baseline in Weighted TNSS Averaged During 3 Hours of Exposure [ Time Frame: Baseline and Day 7 ] [ Designated as safety issue: No ]
  • Change from Baseline in Each Nasal Symptom Score Averaged During 3 Hours of Exposure [ Time Frame: Baseline and Day 7 ] [ Designated as safety issue: No ]
  • Change from Baseline in TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room [ Time Frame: Baseline and 30, 60, 90, 120, 150 and 180 minutes after entering chamber room ] [ Designated as safety issue: No ]
  • Change from Baseline in Weighted TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room [ Time Frame: Baseline and 30, 60, 90, 120, 150 and 180 minutes after entering chamber room ] [ Designated as safety issue: No ]
  • Change from Baseline in Each Nasal Symptom Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room [ Time Frame: Baseline and 30, 60, 90, 120, 150 and 180 minutes after entering chamber room ] [ Designated as safety issue: No ]

Enrollment: 220
Study Start Date: June 2013
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence 1
Participants receiving MK-0476 or Placebo during three treatment periods.
Drug: MK-0476
MK-0476 5 mg chewable tablets, taken orally once daily at bedtime for 7 days
Other Name: montelukast sodium
Drug: Placebo
Matching placebo chewable tablets, taken orally once daily at bedtime for 7 days
Experimental: Sequence 2
Participants receiving MK-0476 or Placebo during three treatment periods.
Drug: MK-0476
MK-0476 5 mg chewable tablets, taken orally once daily at bedtime for 7 days
Other Name: montelukast sodium
Drug: Placebo
Matching placebo chewable tablets, taken orally once daily at bedtime for 7 days

  Eligibility

Ages Eligible for Study:   10 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Weight: ≥ 25 kg
  • Height: ≥ 125 cm
  • Able to record symptoms in a diary
  • Has had allergic rhinitis symptoms [Japanese Cedar (JC) pollinosis]
  • Tested positive for JC pollen specific immunoglobulin E (IgE) antibody assay

Exclusion Criteria:

  • Has nasal findings that would interfere with evaluating nasal congestion symptoms
  • Past or present medical history of bronchial asthma
  • Medical history of allergies except allergic rhinitis and has possibility of dramatically worsening of these symptoms induced by JC pollen exposure
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01857063     History of Changes
Other Study ID Numbers: 0476-519
Study First Received: May 16, 2013
Last Updated: September 16, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014