Study of the Safety and Pharmacokinetics of MK-0476 in the Treatment of Japanese Pediatric Participants With Perennial Allergic Rhinitis (MK-0476-520)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01852812
First received: May 9, 2013
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

This study will evaluate the safety and pharmacokinetics of MK-0476 in the treatment of Japanese pediatric participants with perennial allergic rhinitis (PAR).


Condition Intervention Phase
Perennial Allergic Rhinitis
Drug: MK-0476 Oral Granules (OG)
Drug: MK-0476 Chewable Tablets (CT)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III, Open-Label Clinical Trial to Study the Safety and Pharmacokinetics of MK-0476 in Japanese Pediatric Subjects Aged 1 to 15 Years Old With Perennial Allergic Rhinitis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]
  • Area Under the Curve (AUC) of MK-0476 Chewable Tablets (CT) and MK-0476 Oral Granules (OG) [ Time Frame: Up to Day 28 after first dose of study drug ] [ Designated as safety issue: No ]

Enrollment: 87
Study Start Date: June 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-0476 OG/1-5 year olds/4 or 12 weeks
Participants aged 1 to 5 years old receiving MK-0476 OG for 4 or 12 weeks
Drug: MK-0476 Oral Granules (OG)
MK-0476 4 mg OG, taken once daily at bed time for 4 or 12 weeks
Other Name: montelukast sodium
Experimental: MK-0476 CT/6-9 year olds/12 weeks
Participants aged 6 to 9 years old receiving MK-0476 CT for 12 weeks
Drug: MK-0476 Chewable Tablets (CT)
MK-0476 5 mg CT, taken once daily at bed time for 12 weeks
Other Name: montelukast sodium
Experimental: MK-0476 CT/10-15 year olds/12 weeks
Participants aged 10 to 15 years old receiving MK-0476 CT for 12 weeks
Drug: MK-0476 Chewable Tablets (CT)
MK-0476 5 mg CT, taken once daily at bed time for 12 weeks
Other Name: montelukast sodium

  Eligibility

Ages Eligible for Study:   1 Year to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Weight ≥ 8 kg
  • Diagnosis of PAR and has symptoms of PAR at Visit 1

Exclusion Criteria:

  • Past or present medical history of asthma
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01852812     History of Changes
Other Study ID Numbers: 0476-520
Study First Received: May 9, 2013
Last Updated: January 10, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
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 July 22, 2014