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

NCT01852812 | Completed Phase 3 Results

• 2 other identifiers: 0476-520132233
• Study Type: interventional
• Target: 87
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Perennial Allergic Rhinitis

Outcome Measures

Primary Outcomes (6)

• Percentage of Participants Who Experience at Least One Adverse Event (AE)

  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.

  Up to 14 days after last dose of study drug (Up to 14 weeks)

• Percentage of Participants Who Discontinue Study Drug Due to an AE

  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.

  Up to 12 weeks

• Area Under the Time-Concentration Curve (AUC 0-∞) of Montelukast CT and Montelukast OG

  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.

  Up to Day 28 after first dose of study drug

• Maximum Plasma Concentration (Cmax) of Montelukast CT and Montelukast OG

  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.

  Up to Day 28 after first dose of study drug

• Time to Cmax (Tmax) of Montelukast CT and Montelukast OG

  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.

  Up to Day 28 after first dose of study drug

• Apparent Elimination Half-life (t1/2) of Montelukast CT and Montelukast OG

  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.

  Up to Day 28 after first dose of study drug

Study Arms (3)

Montelukast 4 mg OG/1-5 year olds

EXPERIMENTAL

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 5 mg CT/6-9 year olds

EXPERIMENTAL

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 CT/10-15 year olds

EXPERIMENTAL

Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks

Drug: Montelukast Chewable Tablets (CT)

Interventions

Montelukast Oral Granules (OG) DRUG

Montelukast 4 mg in one sachet

Montelukast 4 mg OG/1-5 year olds

Montelukast Chewable Tablets (CT) DRUG

Montelukast 5 mg in one tablet

Montelukast 5 mg CT/10-15 year olds; Montelukast 5 mg CT/6-9 year olds

Eligibility Criteria

• Age: 1 Year - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (2)

• Okubo K, Inoue Y, Numaguchi H, Tanaka K, Saito I, Oshima N, Matsumoto Y, Prohn M, Mehta A, Nishida C, Philip G. Montelukast in the treatment of perennial allergic rhinitis in paediatric Japanese patients; an open-label clinical trial. J Drug Assess. 2016 Sep 19;5(1):6-14. doi: 10.1080/21556660.2016.1209507. eCollection 2016.

  PMID: 27785374 RESULT

• Hashiguchi K, Okubo K, Inoue Y, Numaguchi H, Tanaka K, Oshima N, Mehta A, Nishida C, Saito I, Philip G. Evaluation of Montelukast for the Treatment of Children With Japanese Cedar Pollinosis Using an Artificial Exposure Chamber (OHIO Chamber). Allergy Rhinol (Providence). 2018 Jul 13;9:2152656718783599. doi: 10.1177/2152656718783599. eCollection 2018 Jan-Dec.

  PMID: 30027002 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2013
• First Posted: May 14, 2013
• Study Start: June 7, 2013
• Primary Completion: December 24, 2013
• Study Completion: December 24, 2013
• Last Updated: June 18, 2024
• Results First Posted: September 29, 2014

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share