Study of the Safety and Pharmacokinetics of Montelukast (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: September 25, 2014
Last verified: September 2014
  Purpose

This study will evaluate the safety and pharmacokinetics of montelukast (MK-0476) in the treatment of Japanese pediatric participants with perennial allergic rhinitis (PAR). The primary hypothesis of this study is that montelukast oral granules (OG) and chewable tablets (CT) provide appropriate exposure to montelukast in Japanese pediatric participants with PAR.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel 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 (AE) [ Time Frame: Up to 14 days after last dose of study drug (Up to 14 weeks) ] [ Designated as safety issue: Yes ]
    An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a pre-existing condition that is temporally associated with the use of study drug is also an AE. Participants were monitored for the occurrence of AEs for up to 14 days after last dose of study drug (up to a total of 14 weeks). AEs were reported based on the dose of study drug participants received.

  • Percentage of Participants Who Discontinue Study Drug Due to an AE [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]
    An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a pre-existing condition that is temporally associated with the use of study drug is also an AE. Discontinuations due to an AE were reported based on the dose of study drug participants received.

  • Area Under the Time-Concentration Curve (AUC 0-∞) of Montelukast CT and Montelukast OG [ Time Frame: Up to Day 28 after first dose of study drug ] [ Designated as safety issue: No ]
    Blood samples for pharmacokinetic (PK) assessments were collected at either 1 hour (h) or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28.

  • Maximum Plasma Concentration (Cmax) of Montelukast CT and Montelukast OG [ Time Frame: Up to Day 28 after first dose of study drug ] [ Designated as safety issue: No ]
    Blood samples for PK assessments were collected at either 1 h or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28.

  • Time to Cmax (Tmax) of Montelukast CT and Montelukast OG [ Time Frame: Up to Day 28 after first dose of study drug ] [ Designated as safety issue: No ]
    Blood samples for PK assessments were collected at either 1 h or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28.

  • Apparent Elimination Half-life (t1/2) of Montelukast CT and Montelukast OG [ Time Frame: Up to Day 28 after first dose of study drug ] [ Designated as safety issue: No ]
    Blood samples for PK assessments were collected at either 1 h or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28.


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: Montelukast 4 mg OG/1-5 year olds
Participants receive montelukast 4 mg OG in one sachet orally (PO) once daily (QD) at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
Drug: Montelukast Oral Granules (OG)
Montelukast 4 mg in one sachet
Experimental: Montelukast 5 mg CT/6-9 year olds
Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
Drug: Montelukast Chewable Tablets (CT)
Montelukast 5 mg in one tablet
Experimental: Montelukast 5 mg CT/10-15 year olds
Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
Drug: Montelukast Chewable Tablets (CT)
Montelukast 5 mg in one tablet

  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
  • Diagosis of acute rhinitis, simple rhinitis, rhinitis congestive, rhinitis atrophic, sinusitis with purulent nasal discharge, rhinitis medicamentosa or nonallergic rhinitis (e.g. vasomotor rhinitis, eosinophilic rhinitis)
  • Started hyposensitization therapy or non-specific immunotherapy within 6 months prior to Visit 1
  • Medical history of inferior concha mucosal resection, submucous resection of inferior turbinates or other surgery aimed at reduction and/or modulation of nasal mucosa (including electrocoagulation, cryoextraction or application of trichloroacetic acid)
  • Clinically significant, active disease of the cardiovascular or hematologic systems or uncontrolled hypertension (1 to 5 year olds: >120/70 mmHg; 6 to 9 year olds: >130/80 mmHg; 10 to 15 year olds: >140/85 mmHg)
  • Medical history of stunted growth
  • Serious drug allergy
  • Treated with other clinical study drug within 3 months prior to Visit 1
  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: NCT01852812

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  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
Results First Received: September 25, 2014
Last Updated: September 25, 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
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 September 30, 2014