Trial · NCT01857063

Study of the Efficacy and Safety of MK-0476 in Japanese Pediatric Participants With Seasonal Allergic Rhinitis (MK-0476-519)

NCT01857063, Phase 3, Completed, Organon and Co; results first posted 2014-05-26

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Study of the Efficacy and Safety of MK-0476 in Japanese Pediatric Participants With Seasonal Allergic Rhinitis (MK-0476-519). Trials, record NCT01857063. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01857063

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of the Efficacy and Safety of MK-0476 in Japanese Pediatric Participants With Seasonal Allergic Rhinitis (MK-0476-519)
NCT number: NCT01857063
Status: Completed
Phases: Phase 3
Enrollment: 220 participants, actual
Lead sponsor: Organon and Co
Conditions: Seasonal Allergic Rhinitis
Interventions: Montelukast, Placebo
First posted: 2013-05-20
Last updated: 2024-06-17
Results first posted: 2014-05-26

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Total Nasal Symptom Score (TNSS) Averaged During 3 Hours of Exposure	Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period	The TNSS is the sum of the three nasal symptom scores for nasal congestion, nasal discharge and sneezing. Participants completed a questionnaire about their nasal symptoms. Score ranged from 0 to 4 for each of the three nasal symptoms, with a total possible score ranging from 0 to 12 and a higher score indicating more severe nasal symptoms. The baseline TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline TNSS was assessed on Day 7 of a treatment period during 3 hours of exposure to Japanes cedar (JC) pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.
Primary	Percentage of Participants Who Experience at Least One Adverse Event	Up to 5 weeks	An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence adverse events for up to 14 days after last dose of study drug. Analysis was done by study drug as taken.
Secondary	Change From Baseline in Weighted TNSS Averaged During 3 Hours of Exposure	Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period	TNSS was weighted as 2:1:1 for nasal congestion, nasal discharge and sneezing. The Weighted TNSS ranged from 0 to 16, with a higher score indicating more severe weighted total nasal symptoms. The baseline Weighted TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline TNSS was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.
Secondary	Change From Baseline in Nasal Congestion Score Averaged During 3 Hours of Exposure	Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period	The Nasal Congestion Score was assessed as 0 = No symptoms of nasal congestion to 4 = Completely obstructed all day, with a possible Nasal Congestion Score ranging from 0 to 4 and a higher score indicating more severe nasal congestion. The baseline Nasal Congestion Score was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline Nasal Congestion Score was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.
Secondary	Change From Baseline in Nasal Discharge Score Averaged During 3 Hours of Exposure	Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period	The Nasal Discharge Score was assessed as 0 = 0 times participant blew his/her nose to 4 = 21 or more times participant blew his/her nose, with a possible Nasal Discharge Score ranging from 0 to 4 and a higher score indicating more severe nasal discharge. The baseline Nasal Discharge Score was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline Nasal Discharge Score was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.
Secondary	Change From Baseline in Sneezing Score Averaged During 3 Hours of Exposure	Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period	The Sneezing Score was assessed as 0 = 0 times participant sneezed to 4 = 21 or more times participant sneezed, with a possible Sneezing Score ranging from 0 to 4 and a higher score indicating more severe sneezing. The baseline Sneezing Score was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline Sneezing Score was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.
Secondary	Change From Baseline in TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room	Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period	The TNSS is the sum of the three nasal symptom scores for nasal congestion, nasal discharge and sneezing. The possible TNSS ranged from 0 to 12, with a higher score indicting more severe total nasal symptoms. The baseline TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline TNSS was assessed on Day 7 of a treatment period at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.
Secondary	Change From Baseline in Weighted TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room	Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period	TNSS was weighted as 2:1:1 for nasal congestion, nasal discharge and sneezing. The possible Weighted TNSS ranged from 0 to 16, with a higher score indicating more severe total nasal symptoms. The baseline TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline Weighted TNSS was assessed on Day 7 of a treatment period at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.
Secondary	Change From Baseline in Nasal Congestion Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room	Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period	The Nasal Congestion Score was assessed as 0 = No symptoms of nasal congestion to 4 = Completely obstructed all day. The possible Nasal Congestion Score ranged from 0 to 4, with a higher score indicating more severe nasal congestion.The Nasal Congestion Score was assessed on Day 7 prior to entering the chamber room and at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.
Secondary	Change From Baseline in Nasal Discharge Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room	Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period	The Nasal Discharge Score was assessed as 0 = 0 times participant blew his/her nose to 4 = 21 or more times participant blew his/her nose. The possible Nasal Discharge Score ranged from 0 to 4, with a higher score indicating more severe nasal discharge.The Nasal Discharge Score was assessed on Day 7 prior to entering the chamber room and at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Total Nasal Symptom Score (TNSS) Averaged During 3 Hours of Exposure	Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period	The Full Analysis Set (FAS) population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.	score on a scale	LEAST_SQUARES_MEAN
PRIMARY	Percentage of Participants Who Experience at Least One Adverse Event	Up to 5 weeks	The All Patients as Treated (APaT) population consisted of all randomized participants who received at least one dose of study drug.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in Weighted TNSS Averaged During 3 Hours of Exposure	Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period	The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Nasal Congestion Score Averaged During 3 Hours of Exposure	Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period	The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Nasal Discharge Score Averaged During 3 Hours of Exposure	Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period	The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Sneezing Score Averaged During 3 Hours of Exposure	Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period	The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room	Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period	The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Weighted TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room	Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period	The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Nasal Congestion Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room	Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period	The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Nasal Discharge Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room	Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period	The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.	score on a scale	LEAST_SQUARES_MEAN

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group72

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Total Nasal Symptom Score (TNSS) Averaged During 3 Hours of Exposure	Montelukast	1.17	95% Confidence Interval 1.03 to 1.31	score on a scale
Change From Baseline in Total Nasal Symptom Score (TNSS) Averaged During 3 Hours of Exposure	Placebo	1.18	95% Confidence Interval 1.04 to 1.32	score on a scale
Percentage of Participants Who Experience at Least One Adverse Event	Montelukast	10.2		percentage of participants
Percentage of Participants Who Experience at Least One Adverse Event	Placebo	16.5		percentage of participants
Change From Baseline in Weighted TNSS Averaged During 3 Hours of Exposure	Montelukast	1.85	95% Confidence Interval 1.63 to 2.07	score on a scale
Change From Baseline in Weighted TNSS Averaged During 3 Hours of Exposure	Placebo	1.86	95% Confidence Interval 1.63 to 2.08	score on a scale
Change From Baseline in Nasal Congestion Score Averaged During 3 Hours of Exposure	Montelukast	0.68	95% Confidence Interval 0.59 to 0.76	score on a scale
Change From Baseline in Nasal Congestion Score Averaged During 3 Hours of Exposure	Placebo	0.68	95% Confidence Interval 0.59 to 0.76	score on a scale
Change From Baseline in Nasal Discharge Score Averaged During 3 Hours of Exposure	Montelukast	0.29	95% Confidence Interval 0.25 to 0.34	score on a scale
Change From Baseline in Nasal Discharge Score Averaged During 3 Hours of Exposure	Placebo	0.32	95% Confidence Interval 0.27 to 0.37	score on a scale

1 to 10 of 72Source ClinicalTrials.gov

See all 72 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Period 1 (7 Days)	STARTED	Montelukast/Placebo	110
Period 1 (7 Days)	STARTED	Placebo/Montelukast	110
Period 1 (7 Days)	COMPLETED	Montelukast/Placebo	108
Period 1 (7 Days)	COMPLETED	Placebo/Montelukast	106
Period 1 (7 Days)	NOT COMPLETED	Montelukast/Placebo	2
Period 1 (7 Days)	NOT COMPLETED	Placebo/Montelukast	4
Period 2 (7 Days)	STARTED	Montelukast/Placebo	108
Period 2 (7 Days)	STARTED	Placebo/Montelukast	106
Period 2 (7 Days)	COMPLETED	Montelukast/Placebo	104
Period 2 (7 Days)	COMPLETED	Placebo/Montelukast	104

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events2

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	Protein urine present	Investigations	Montelukast	10	216	10
other	Protein urine present	Investigations	Placebo	17	218	17

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Montelukast
Total, all-cause mortality	Placebo
Total, other adverse events	Montelukast	10	216
Total, other adverse events	Placebo	17	218
Total, serious adverse events	Montelukast	0	216
Total, serious adverse events	Placebo	0	218

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
30027002	RESULT

Source PubMed

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 vs Placebo: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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