Trial · NCT00968149

A Study Comparing Montelukast With Placebo in Children With Seasonal Allergic Rhinitis (0476-219)(COMPLETED)

NCT00968149, Phase 3, Completed, Organon and Co; results first posted 2009-12-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study Comparing Montelukast With Placebo in Children With Seasonal Allergic Rhinitis (0476-219)(COMPLETED). Trials, record NCT00968149. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00968149

On this page

Trial

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

Title: A Study Comparing Montelukast With Placebo in Children With Seasonal Allergic Rhinitis (0476-219)(COMPLETED)
NCT number: NCT00968149
Status: Completed
Phases: Phase 3
Enrollment: 413 participants, actual
Lead sponsor: Organon and Co
Conditions: Seasonal Allergic Rhinitis
Interventions: montelukast sodium, Comparator: Placebo
First posted: 2009-08-28
Last updated: 2022-02-03
Results first posted: 2009-12-11
Limitations and caveats: Efficacy endpoints are exploratory.

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame	Description
Primary	Number of Patients With Clinical Adverse Experiences (CAEs)	2 weeks	A clinical adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Secondary	Number of Patients With Serious CAEs	2 weeks	Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
Secondary	Number of Patients With Drug-related CAEs	2 weeks	Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
Secondary	Number of Patients Who Were Discontinued Due to CAEs	2 weeks
Secondary	Number of Patients With Laboratory Adverse Experiences (LAEs)	2 weeks	A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Secondary	Number of Patients With Serious LAEs	2 weeks	Serious LAEs are any LAEs occurring at any dose that: Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
Secondary	Number of Patients With Drug-related LAEs	2 weeks
Secondary	Number of Patients Who Were Discontinued Due to LAEs	2 weeks

Source ClinicalTrials.gov

Outcomes8

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Patients With Clinical Adverse Experiences (CAEs)	2 weeks	All patients who took study medication during the 2-week, double-blind treatment period were included in the analysis.	Participants	NUMBER
SECONDARY	Number of Patients With Serious CAEs	2 weeks	All patients who took study medication during the 2-week, double-blind treatment period were included in the analysis.	Participants	NUMBER
SECONDARY	Number of Patients With Drug-related CAEs	2 weeks	All patients who took study medication during the 2-week, double-blind treatment period were included in the analysis.	Participants	NUMBER
SECONDARY	Number of Patients Who Were Discontinued Due to CAEs	2 weeks	All patients who took study medication during the 2-week, double-blind treatment period were included in the analysis.	Participants	NUMBER
SECONDARY	Number of Patients With Laboratory Adverse Experiences (LAEs)	2 weeks	All patients who took study medication during the 2-week, double-blind treatment period and had at least one laboratory test post baseline were included in the analysis.	Participants	NUMBER
SECONDARY	Number of Patients With Serious LAEs	2 weeks	All patients who took study medication during the 2-week, double-blind treatment period and had at least one laboratory test post baseline were included in the analysis.	Participants	NUMBER
SECONDARY	Number of Patients With Drug-related LAEs	2 weeks	All patients who took study medication during the 2-week, double-blind treatment period and had at least one laboratory test post baseline were included in the analysis.	Participants	NUMBER
SECONDARY	Number of Patients Who Were Discontinued Due to LAEs	2 weeks	All patients who took study medication during the 2-week, double-blind treatment period and had at least one laboratory test post baseline were included in the analysis.	Participants	NUMBER

Source ClinicalTrials.gov

Results by group32

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

Outcome	Group	Category	Value	Units
Number of Patients With Clinical Adverse Experiences (CAEs)	Montelukast 4 mg and 5 mg	With CAEs	73	Participants
Number of Patients With Clinical Adverse Experiences (CAEs)	Placebo	With CAEs	35	Participants
Number of Patients With Clinical Adverse Experiences (CAEs)	Montelukast 4 mg and 5 mg	Without CAEs	207	Participants
Number of Patients With Clinical Adverse Experiences (CAEs)	Placebo	Without CAEs	98	Participants
Number of Patients With Serious CAEs	Montelukast 4 mg and 5 mg	With Serious CAEs	1	Participants
Number of Patients With Serious CAEs	Placebo	With Serious CAEs	0	Participants
Number of Patients With Serious CAEs	Montelukast 4 mg and 5 mg	Without Serious CAEs	279	Participants
Number of Patients With Serious CAEs	Placebo	Without Serious CAEs	133	Participants
Number of Patients With Drug-related CAEs	Montelukast 4 mg and 5 mg	With Drug-related CAEs	10	Participants
Number of Patients With Drug-related CAEs	Placebo	With Drug-related CAEs	5	Participants

1 to 10 of 32Source ClinicalTrials.gov

See all 32 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Montelukast 4 mg and 5 mg	280
Overall Study	STARTED	Placebo	133
Overall Study	COMPLETED	Montelukast 4 mg and 5 mg	269
Overall Study	COMPLETED	Placebo	127
Overall Study	NOT COMPLETED	Montelukast 4 mg and 5 mg	11
Overall Study	NOT COMPLETED	Placebo	6

Source ClinicalTrials.gov

Adverse events152

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
other	Abdominal Pain	General disorders	Montelukast 4 mg and 5 mg	4	280
other	Abdominal Pain	General disorders	Placebo	2	133
other	Asthenia/Fatigue	General disorders	Montelukast 4 mg and 5 mg	2	280
other	Asthenia/Fatigue	General disorders	Placebo	0	133
other	Body Ache	General disorders	Montelukast 4 mg and 5 mg	1	280
other	Body Ache	General disorders	Placebo	0	133
other	Contusion	Injury, poisoning and procedural complications	Montelukast 4 mg and 5 mg	0	280
other	Contusion	Injury, poisoning and procedural complications	Placebo	1	133
other	Dizziness	Nervous system disorders	Montelukast 4 mg and 5 mg	0	280
other	Dizziness	Nervous system disorders	Placebo	1	133

1 to 10 of 152Source ClinicalTrials.gov

See all 152 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Montelukast 4 mg and 5 mg
Total, all-cause mortality	Placebo
Total, other adverse events	Montelukast 4 mg and 5 mg	73	280
Total, other adverse events	Placebo	35	133
Total, serious adverse events	Montelukast 4 mg and 5 mg	1	280
Total, serious adverse events	Placebo	0	133

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
19449366	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 4 mg and 5 mg 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.

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/NCT00968149

GET https://conductscience.org/api/trials/v1/NCT00968149/results?page=2

API reference For AI assistants