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NCT Number: NCT01852812

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 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.

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Key information

Conditions

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

Age range

1 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Montelukast Oral Granules (OG)

Drug

Montelukast 4 mg in one sachet

Montelukast Chewable Tablets (CT)

Drug

Montelukast 5 mg in one tablet

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 14, 2013
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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