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

Primary Purpose

Perennial Allergic Rhinitis

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Montelukast Oral Granules (OG)

Montelukast Chewable Tablets (CT)

About this trial

This is an interventional treatment trial for Perennial Allergic Rhinitis

Eligibility Criteria

1 Year - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Montelukast 4 mg OG/1-5 year olds

Montelukast 5 mg CT/6-9 year olds

Montelukast 5 mg CT/10-15 year olds

Arm Description

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)

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

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01852812

First Posted

May 9, 2013

Last Updated

February 7, 2022

Sponsor

Organon and Co

1. Study Identification

Unique Protocol Identification Number

NCT01852812

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

June 7, 2013 (Actual)

Primary Completion Date

December 24, 2013 (Actual)

Study Completion Date

December 24, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Organon and Co

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Perennial Allergic Rhinitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

87 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Montelukast 4 mg OG/1-5 year olds

Arm Type

Experimental

Arm Description

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)

Arm Title

Montelukast 5 mg CT/6-9 year olds

Arm Type

Experimental

Arm Description

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

Arm Title

Montelukast 5 mg CT/10-15 year olds

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Montelukast Oral Granules (OG)

Intervention Description

Montelukast 4 mg in one sachet

Intervention Type

Drug

Intervention Name(s)

Montelukast Chewable Tablets (CT)

Intervention Description

Montelukast 5 mg in one tablet

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

Percentage of Participants Who Discontinue Study Drug Due to an AE

Description

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.

Time Frame

Up to 12 weeks

Title

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

Description

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.

Time Frame

Up to Day 28 after first dose of study drug

Title

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

Description

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 Frame

Up to Day 28 after first dose of study drug

Title

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

Description

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 Frame

Up to Day 28 after first dose of study drug

Title

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

Description

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 Frame

Up to Day 28 after first dose of study drug

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

IPD Sharing URL

http://engagezone.msd.com/ds_documentation.php

Citations:

PubMed Identifier

27785374

Citation

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.

Results Reference

result

PubMed Identifier

30027002

Citation

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. Erratum In: Allergy Rhinol (Providence). 2018 Aug 22;9:2152656718797803.

Results Reference

derived

Available IPD and Supporting Information:

Available IPD/Information Type

CSR Synopsis

Available IPD/Information URL

http://www.merck.com/clinical-trials/study.html?id=0476-520&kw=0476-520&tab=access

Learn more about this trial

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

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