Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...