Perennial Allergic RhinitisPhase 3NCT01852812

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

A Phase 3 study testing Montelukast Oral Granules (OG) and Montelukast Chewable Tablets (CT) in people with Perennial Allergic Rhinitis, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 1 year to 15 years
Conditions the study is for: Perennial Allergic Rhinitis
What is being tested?: Montelukast Oral Granules (OG) and Montelukast Chewable Tablets (CT)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 87 participants
Where: No sites listed yet
Study dates: 7 Jun 2013to 24 Dec 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 year to 15 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

About this study

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

Conditions: Perennial Allergic Rhinitis
Being tested: Montelukast Oral Granules (OG), Montelukast Chewable Tablets (CT)
Medical subject headings: Rhinitis, Allergic, Perennial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Montelukast Oral Granules (OG)Drug
Montelukast 4 mg in one sachet
Montelukast Chewable Tablets (CT)Drug
Montelukast 5 mg in one tablet

Study groups in NCT01852812
Study group	Role	What they receive
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) Receives: 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 Receives: 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 Receives: Drug: Montelukast Chewable Tablets (CT)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Day 28 after first dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jun 201324 Dec 2013

First posted14 May 2013 (estimated)
Study start7 Jun 2013
Primary completion24 Dec 2013
Study completion24 Dec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Perennial Allergic RhinitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 87 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01852812
Sponsor's protocol ID: 0476-520
Other IDs: 132233
Status last verified: Feb 2022
First submitted: 9 May 2013
Last updated: 18 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 27785374
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.
PubMed 30027002

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Perennial Allergic Rhinitis (PAR)
Not yet recruitingPhase 2
Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
Perennial Allergic Rhinitis (PAR)
RecruitingObservational study
Identification of B Regulatory Cells by Flow Cytometry
Pollen Allergy, Venom Allergy
Not yet recruitingPhase 4
A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
Rhinitis Allergic, Rhinitis Seasonal
Active, not recruitingPhase 2
Dupilumab Effects Against Aeroallergen Challenge
Asthma, Allergic

All Perennial Allergic Rhinitis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01852812
Acronym / sponsor ID: 0476-520
Conditions: Perennial Allergic Rhinitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 87 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: 7 Jun 2013 (actual)
Primary completion: 24 Dec 2013 (actual)
Study completion: 24 Dec 2013 (actual)
First posted: 14 May 2013 (estimated)
Results: Posted 29 Sep 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Montelukast 4 mg OG/1-5 year olds	Experimental	Drug: Montelukast Oral Granules (OG)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)
Montelukast 5 mg CT/6-9 year olds	Experimental	Drug: Montelukast Chewable Tablets (CT)Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
Montelukast 5 mg CT/10-15 year olds	Experimental	Drug: Montelukast Chewable Tablets (CT)Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks

Who may qualify

Ages: 1 year to 15 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

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

Key exclusion criteria (8 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Montelukast Oral Granules (OG)Montelukast 4 mg in one sachet	Drug	Montelukast 4 mg OG/1-5 year olds
Montelukast Chewable Tablets (CT)Montelukast 5 mg in one tablet	Drug	Montelukast 5 mg CT/10-15 year olds, Montelukast 5 mg CT/6-9 year olds

Primary outcome

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)
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
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
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
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
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
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.

Results and safety

Results posted to the registry on 29 Sep 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Montelukast 4 mg OG/1-5 Year Olds	51	51
Montelukast 5 mg CT/6-9 Year Olds	18	17
Montelukast 5 mg CT/10-15 Year Olds	18	17

Primary outcome: 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). Number. Unit: Percentage of participants

Measure	Montelukast 4 mg OG/1-5 Year Olds n = 51	Montelukast 5 mg CT/6-15 Year Olds n = 36
Value	74.5	55.6

Population analysed: The All Subjects as Treated (ASaT) population consisted of all participants who received at least one dose of study drug. Data from the two montelukast 5 mg CT groups (6-9 year olds and 10-15 year olds) were pooled for safety analyses.

Primary outcome: Percentage of Participants Who Discontinue Study Drug Due to an AE

Time frame: Up to 12 weeks. Number. Unit: Percentage of participants

Measure	Montelukast 4 mg OG/1-5 Year Olds n = 51	Montelukast 5 mg CT/6-15 Year Olds n = 36
Value	0.0	2.8

Population analysed: The ASaT population consisted of all participants who received at least one dose of study drug. Data from the two montelukast 5 mg CT groups (6-9 year olds and 10-15 year olds) were pooled for safety analyses.

Primary outcome: 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. Mean (Standard Deviation). Unit: h*ng/mL

Measure	Montelukast 4 mg OG/1-5 Year Olds n = 51	Montelukast 5 mg CT/6-9 Year Olds n = 18	Montelukast 5 mg CT/10-15 Year Olds n = 18
Value	4300 (800)	4350 (760)	3500 (620)

Population analysed: The All Subjects Pharmacokinetically Evaluable (ASPE) population consisted of all participants from the ASaT population who had an evaluable assessement for this PK parameter and did not have any protocol violation which would interfere with this PK parameter. Data for PK assessments were reported by dose of study drug received and age group.

Primary outcome: Maximum Plasma Concentration (Cmax) of Montelukast CT and Montelukast OG

Time frame: Up to Day 28 after first dose of study drug. Mean (Standard Deviation). Unit: ng/mL

Measure	Montelukast 4 mg OG/1-5 Year Olds n = 51	Montelukast 5 mg CT/6-9 Year Olds n = 18	Montelukast 5 mg CT/10-15 Year Olds n = 18
Value	510 (84)	438 (82)	344 (61)

Population analysed: The ASPE population consisted of all participants from the ASaT population who had an evaluable assessement for this PK parameter and did not have any protocol violation which would interfere with this PK parameter. Data for PK assessments were reported by dose of study drug received and age group.

Adverse events

Time frame: Up to 14 days after last dose of study drug (Up to 14 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Montelukast 4 mg OG/1-5 Year Olds	0 of 51 (0%)	37 of 51 (72.5%)	Not reported
Montelukast 5 mg CT/6-15 Year Olds	0 of 36 (0%)	18 of 36 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27785374Okubo 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.
Derived from this study: PubMed 30027002Hashiguchi 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.
Individual participant dataSharing planned: No

Related trials for Perennial Allergic Rhinitis

Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Perennial Allergic Rhinitis (PAR)
Not yet recruitingPhase 2
Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
Perennial Allergic Rhinitis (PAR)
RecruitingObservational study
Identification of B Regulatory Cells by Flow Cytometry
Pollen Allergy, Venom Allergy
Not yet recruitingPhase 4
A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
Rhinitis Allergic, Rhinitis Seasonal
Active, not recruitingPhase 2
Dupilumab Effects Against Aeroallergen Challenge
Asthma, Allergic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Montelukast Oral Granules (OG) and Montelukast Chewable Tablets (CT) in people with Perennial Allergic Rhinitis, run by Organon and Co.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01852812, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.