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.
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
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
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
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
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 27785374Hashiguchi 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