Trial · 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)
NCT01852812, Phase 3, Completed, Organon and Co; results first posted 2014-09-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of the Safety and Pharmacokinetics of Montelukast (MK-0476) in the Treatment of Japanese Pediatric Participants With Perennial Allergic Rhinitis (MK-0476-520). Trials, record NCT01852812. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01852812
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Safety and Pharmacokinetics of Montelukast (MK-0476) in the Treatment of Japanese Pediatric Participants With Perennial Allergic Rhinitis (MK-0476-520)
- NCT number
- NCT01852812
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 87 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Perennial Allergic Rhinitis
- Interventions
- Montelukast Oral Granules (OG), Montelukast Chewable Tablets (CT)
- First posted
- 2013-05-14
- Last updated
- 2024-06-18
- Results first posted
- 2014-09-29
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Experience at Least One Adverse Event (AE) | 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. |
| Primary | Percentage of Participants Who Discontinue Study Drug Due to an AE | 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. |
| Primary | Area Under the Time-Concentration Curve (AUC 0-∞) of Montelukast CT and Montelukast OG | 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. |
| Primary | Maximum Plasma Concentration (Cmax) of Montelukast CT and Montelukast OG | 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. |
| Primary | Time to Cmax (Tmax) of Montelukast CT and Montelukast OG | 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. |
| Primary | Apparent Elimination Half-life (t1/2) of Montelukast CT and Montelukast OG | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Experience at Least One Adverse Event (AE) | Up to 14 days after last dose of study drug (Up to 14 weeks) | 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. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Discontinue Study Drug Due to an AE | Up to 12 weeks | 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. | Percentage of participants | NUMBER |
| PRIMARY | Area Under the Time-Concentration Curve (AUC 0-∞) of Montelukast CT and Montelukast OG | Up to Day 28 after first dose of study drug | 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. | h*ng/mL | MEAN |
| PRIMARY | Maximum Plasma Concentration (Cmax) of Montelukast CT and Montelukast OG | Up to Day 28 after first dose of study drug | 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. | ng/mL | MEAN |
| PRIMARY | Time to Cmax (Tmax) of Montelukast CT and Montelukast OG | Up to Day 28 after first dose of study drug | 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. | Hours | MEAN |
| PRIMARY | Apparent Elimination Half-life (t1/2) of Montelukast CT and Montelukast OG | Up to Day 28 after first dose of study drug | 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. | Hours | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Experience at Least One Adverse Event (AE) | Montelukast 4 mg OG/1-5 Year Olds | 74.5 | Percentage of participants | ||
| Percentage of Participants Who Experience at Least One Adverse Event (AE) | Montelukast 5 mg CT/6-15 Year Olds | 55.6 | Percentage of participants | ||
| Percentage of Participants Who Discontinue Study Drug Due to an AE | Montelukast 4 mg OG/1-5 Year Olds | 0.0 | Percentage of participants | ||
| Percentage of Participants Who Discontinue Study Drug Due to an AE | Montelukast 5 mg CT/6-15 Year Olds | 2.8 | Percentage of participants | ||
| Area Under the Time-Concentration Curve (AUC 0-∞) of Montelukast CT and Montelukast OG | Montelukast 4 mg OG/1-5 Year Olds | 4300 | Standard Deviation 800 | h*ng/mL | |
| Area Under the Time-Concentration Curve (AUC 0-∞) of Montelukast CT and Montelukast OG | Montelukast 5 mg CT/6-9 Year Olds | 4350 | Standard Deviation 760 | h*ng/mL | |
| Area Under the Time-Concentration Curve (AUC 0-∞) of Montelukast CT and Montelukast OG | Montelukast 5 mg CT/10-15 Year Olds | 3500 | Standard Deviation 620 | h*ng/mL | |
| Maximum Plasma Concentration (Cmax) of Montelukast CT and Montelukast OG | Montelukast 4 mg OG/1-5 Year Olds | 510 | Standard Deviation 84 | ng/mL | |
| Maximum Plasma Concentration (Cmax) of Montelukast CT and Montelukast OG | Montelukast 5 mg CT/6-9 Year Olds | 438 | Standard Deviation 82 | ng/mL | |
| Maximum Plasma Concentration (Cmax) of Montelukast CT and Montelukast OG | Montelukast 5 mg CT/10-15 Year Olds | 344 | Standard Deviation 61 | ng/mL |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Montelukast 4 mg OG/1-5 Year Olds | 51 | |
| Overall Study | STARTED | Montelukast 5 mg CT/6-9 Year Olds | 18 | |
| Overall Study | STARTED | Montelukast 5 mg CT/10-15 Year Olds | 18 | |
| Overall Study | COMPLETED | Montelukast 4 mg OG/1-5 Year Olds | 51 | |
| Overall Study | COMPLETED | Montelukast 5 mg CT/6-9 Year Olds | 17 | |
| Overall Study | COMPLETED | Montelukast 5 mg CT/10-15 Year Olds | 17 | |
| Overall Study | NOT COMPLETED | Montelukast 4 mg OG/1-5 Year Olds | 0 | |
| Overall Study | NOT COMPLETED | Montelukast 5 mg CT/6-9 Year Olds | 1 | |
| Overall Study | NOT COMPLETED | Montelukast 5 mg CT/10-15 Year Olds | 1 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Montelukast 4 mg OG/1-5 Year Olds | 4 | 51 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | Montelukast 5 mg CT/6-15 Year Olds | 0 | 36 | 0 |
| other | Acute sinusitis | Infections and infestations | Montelukast 4 mg OG/1-5 Year Olds | 6 | 51 | 8 |
| other | Acute sinusitis | Infections and infestations | Montelukast 5 mg CT/6-15 Year Olds | 0 | 36 | 0 |
| other | Bronchitis | Infections and infestations | Montelukast 4 mg OG/1-5 Year Olds | 3 | 51 | 4 |
| other | Bronchitis | Infections and infestations | Montelukast 5 mg CT/6-15 Year Olds | 3 | 36 | 3 |
| other | Gastroenteritis | Infections and infestations | Montelukast 4 mg OG/1-5 Year Olds | 3 | 51 | 3 |
| other | Gastroenteritis | Infections and infestations | Montelukast 5 mg CT/6-15 Year Olds | 1 | 36 | 1 |
| other | Hand-foot-and-mouth disease | Infections and infestations | Montelukast 4 mg OG/1-5 Year Olds | 3 | 51 | 3 |
| other | Hand-foot-and-mouth disease | Infections and infestations | Montelukast 5 mg CT/6-15 Year Olds | 0 | 36 | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Montelukast 4 mg OG/1-5 Year Olds | ||
| Total, all-cause mortality | Montelukast 5 mg CT/6-15 Year Olds | ||
| Total, other adverse events | Montelukast 4 mg OG/1-5 Year Olds | 37 | 51 |
| Total, other adverse events | Montelukast 5 mg CT/6-15 Year Olds | 18 | 36 |
| Total, serious adverse events | Montelukast 4 mg OG/1-5 Year Olds | 0 | 51 |
| Total, serious adverse events | Montelukast 5 mg CT/6-15 Year Olds | 0 | 36 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Montelukast 4 mg OG/1-5 Year Olds vs Montelukast 5 mg CT/6-15 Year Olds: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01852812
GET https://conductscience.org/api/trials/v1/NCT01852812/events?page=2