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Also known as Montelukast Oral Granules (OG)
Montelukast Granules · 1 trial · 1 indication
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.
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.
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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) |
| 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 |
| 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 |
| Name | Type | Description |
|---|---|---|
| Montelukast Oral Granules (OG) | DRUG | Montelukast 4 mg in one sachet |
| Montelukast Chewable Tablets (CT) | DRUG | Montelukast 5 mg in one tablet |
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 medicam...
Montelukast Granules is being developed for the treatment of perennial allergic rhinitis, a year-round allergic condition. It is an oral granule formulation studied in Japanese pediatric participants aged 1 year and older. The program is in Phase 3 development and is not approved for this use.
Montelukast Granules targets CYSLTR1, the cysteinyl leukotriene receptor 1. It acts as an antagonist at this receptor, blocking leukotriene-mediated signaling that contributes to allergic inflammation in the airways. This mechanism underlies its investigation in perennial allergic rhinitis.
Montelukast Granules is being developed by Organon & Co., which trades under the ticker OGN. Organon is the sponsor of the clinical program evaluating this oral granule formulation for perennial allergic rhinitis.
Montelukast Granules is in Phase 3 development. The program includes one completed Phase 3 trial, and no trials are currently active. It is an investigational formulation and has not been approved for perennial allergic rhinitis.
Montelukast Granules has been studied in one completed Phase 3 trial, NCT01852812, titled a study of the safety and pharmacokinetics of montelukast (MK-0476) in Japanese pediatric participants with perennial allergic rhinitis. The trial enrolled 87 participants aged 1 year and older and used a controlled design.
Yes, Montelukast Granules is also known as Montelukast Oral Granules (OG). Both names refer to the same oral granule formulation of montelukast developed by Organon for perennial allergic rhinitis.