Trial · NCT00974571

Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246)

NCT00974571, Phase 3, Completed, Organon and Co; results first posted 2010-06-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246). Trials, record NCT00974571. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00974571

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Trial

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

Title: Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246)
NCT number: NCT00974571
Status: Completed
Phases: Phase 3
Enrollment: 1,365 participants, actual
Lead sponsor: Organon and Co
Conditions: Perennial Allergic Rhinitis
Interventions: montelukast sodium, Comparator: cetirizine, Comparator: placebo
First posted: 2009-09-10
Last updated: 2022-02-03
Results first posted: 2010-06-07

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Mean Change From Baseline in Daytime Nasal Symptoms Score	Baseline and first 4 weeks of a 6-week treatment period	Mean change from baseline in Daytime Nasal Symptoms score. Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale \[Score 0 (best) to 3 (worst)\]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.
Secondary	Mean Change From Baseline in Nighttime Symptoms Score	Baseline and first 4 weeks in 6-week treatment period	Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale \[Score 0 (best) to 3 (worst)\], and the average score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score.
Secondary	Mean Change From Baseline in Composite Symptoms Score	Baseline and first 4 weeks in 6-week treatment period	Composite Symptoms Scores were computed as the average of the Daytime Nasal Symptoms Scores \[Score 0 (best) to 3 (worst)\]. and Nighttime Symptoms Scores collected \[Score 0 (best) to 3 (worst)\].
Secondary	Patient's Global Evaluation of Allergic Rhinitis	End of the first 4 weeks in 6-week treatment period	An evaluation by the patient, administered at week 4 of the study (or upon discontinuation) using a 7-point scale \[Score 0 (best) to 6 (worst)\], of the change in symptoms as compared to the beginning of the study.
Secondary	Physician's Global Evaluation of Allergic Rhinitis	End of the first 4 weeks in 6-week treatment period	An evaluation by the physician, administered at week 4 of the study (or upon discontinuation) using a 7-point scale \[Score 0 (best) to 6 (worst)\], of the change in symptoms as compared to the beginning of the study.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Change From Baseline in Daytime Nasal Symptoms Score	Baseline and first 4 weeks of a 6-week treatment period	All patients who had a baseline and at least one posttreatment measurement were included.	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline in Nighttime Symptoms Score	Baseline and first 4 weeks in 6-week treatment period	All patients who had a baseline and at least one posttreatment measurement were included.	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline in Composite Symptoms Score	Baseline and first 4 weeks in 6-week treatment period	All patients who had a baseline and at least one posttreatment measurement were included.	Score 0 (best) to 3 (worst)	LEAST_SQUARES_MEAN
SECONDARY	Patient's Global Evaluation of Allergic Rhinitis	End of the first 4 weeks in 6-week treatment period	The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Physician's Global Evaluation of Allergic Rhinitis	End of the first 4 weeks in 6-week treatment period	The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.	Scores on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group15

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

Outcome	Group	Value	Spread	Units
Mean Change From Baseline in Daytime Nasal Symptoms Score	Montelukast 10 mg	-0.39	95% Confidence Interval -0.43 to -0.36	Scores on a scale
Mean Change From Baseline in Daytime Nasal Symptoms Score	Cetirizine 10 mg	-0.45	95% Confidence Interval -0.54 to -0.37	Scores on a scale
Mean Change From Baseline in Daytime Nasal Symptoms Score	Placebo	-0.36	95% Confidence Interval -0.39 to -0.32	Scores on a scale
Mean Change From Baseline in Nighttime Symptoms Score	Montelukast 10 mg	-0.28	95% Confidence Interval -0.32 to -0.25	Scores on a scale
Mean Change From Baseline in Nighttime Symptoms Score	Cetirizine 10 mg	-0.30	95% Confidence Interval -0.38 to -0.23	Scores on a scale
Mean Change From Baseline in Nighttime Symptoms Score	Placebo	-0.26	95% Confidence Interval -0.29 to -0.22	Scores on a scale
Mean Change From Baseline in Composite Symptoms Score	Montelukast 10 mg	-0.34	95% Confidence Interval -0.37 to -0.31	Score 0 (best) to 3 (worst)
Mean Change From Baseline in Composite Symptoms Score	Cetirizine 10 mg	-0.38	95% Confidence Interval -0.45 to -0.31	Score 0 (best) to 3 (worst)
Mean Change From Baseline in Composite Symptoms Score	Placebo	-0.30	95% Confidence Interval -0.34 to -0.27	Score 0 (best) to 3 (worst)
Patient's Global Evaluation of Allergic Rhinitis	Montelukast 10 mg	2.22	95% Confidence Interval 2.11 to 2.32	Scores on a scale

1 to 10 of 15Source ClinicalTrials.gov

See all 15 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Montelukast 10 mg	630
Overall Study	STARTED	Cetirizine 10 mg	122
Overall Study	STARTED	Placebo	613
Overall Study	COMPLETED	Montelukast 10 mg	562
Overall Study	COMPLETED	Cetirizine 10 mg	106
Overall Study	COMPLETED	Placebo	530
Overall Study	NOT COMPLETED	Montelukast 10 mg	68
Overall Study	NOT COMPLETED	Cetirizine 10 mg	16
Overall Study	NOT COMPLETED	Placebo	83

Source ClinicalTrials.gov

Adverse events15

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	Upper Respiratory Infection	Infections and infestations	Montelukast 10 mg	41	630
other	Upper Respiratory Infection	Infections and infestations	Cetirizine 10 mg	8	122
other	Upper Respiratory Infection	Infections and infestations	Placebo	34	613
other	Headache	Nervous system disorders	Montelukast 10 mg	47	630
other	Headache	Nervous system disorders	Cetirizine 10 mg	8	122
other	Headache	Nervous system disorders	Placebo	36	613
serious	Laceration	Injury, poisoning and procedural complications	Montelukast 10 mg	1	630
serious	Laceration	Injury, poisoning and procedural complications	Cetirizine 10 mg	0	122
serious	Laceration	Injury, poisoning and procedural complications	Placebo	0	613
serious	Unstable Angina	Cardiac disorders	Montelukast 10 mg	0	630

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Montelukast 10 mg
Total, all-cause mortality	Cetirizine 10 mg
Total, all-cause mortality	Placebo
Total, other adverse events	Montelukast 10 mg	85	630
Total, other adverse events	Cetirizine 10 mg	16	122
Total, other adverse events	Placebo	65	613
Total, serious adverse events	Montelukast 10 mg	2	630
Total, serious adverse events	Cetirizine 10 mg	0	122
Total, serious adverse events	Placebo	3	613

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
17619558	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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

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GET https://conductscience.org/api/trials/v1/NCT00974571/registered

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