Trial · NCT00963599

Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117)

NCT00963599, Phase 3, Completed, Organon and Co; results first posted 2010-06-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117). Trials, record NCT00963599. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00963599

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Trial

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

Title: Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117)
NCT number: NCT00963599
Status: Completed
Phases: Phase 3
Enrollment: 907 participants, actual
Lead sponsor: Organon and Co
Conditions: Seasonal Allergic Rhinitis
Interventions: Comparator: montelukast/loratadine, Comparator: montelukast, Comparator: loratadine, Comparator: placebo
First posted: 2009-08-21
Last updated: 2022-02-09
Results first posted: 2010-06-16

Source ClinicalTrials.gov

Registered outcomes12

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 Week 2	Mean change from baseline in Daytime Nasal Symptoms score. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale (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 Week 2	Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale (0 (best) to 3 (worst)), and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score.
Secondary	Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms)	Baseline and Week 2	Composite Symptoms scores were computed as the average of the Daytime Nasal Symptoms scores and Nighttime Symptoms scores collected on a 4 point scale (0 (best) to 3 (worst)).
Secondary	Mean Change From Baseline in Daytime Eye Symptoms Score	Baseline and Week 2	Mean change from baseline in Daytime Eye Symptoms scores. Patients were asked to rate each of the 4 eye symptom of tearing, itchy, red, and puffy eyes daily on a 4-point scale (0 (best) to 3 (worst)). The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score.
Secondary	Mean Change From Baseline in Daytime Nasal Congestion Score	Baseline and Week 2	Patients were asked to rate the nasal symptom of Congestion daily on a 4-point scale (0 (best) to 3 (worst)).
Secondary	Mean Change From Baseline in Daytime Rhinorrhea Score	Baseline and Week 2	Patients were asked to rate the nasal symptom of Rhinorrhea daily on a 4-point scale (0 (best) to 3 (worst)).
Secondary	Mean Change From Baseline in Daytime Nasal Itching Score	Baseline and Week 2	Patients were asked to rate the nasal symptom of Nasal Itching daily on a 4-point scale (0 (best) to 3 (worst)).
Secondary	Mean Change From Baseline in Daytime Sneezing Score	Baseline and Week 2	Patients were asked to rate the nasal symptom of Sneezing daily on a 4-point scale (0 (best) to 3 (worst)).
Secondary	Mean Change From Baseline in Nasal Congestion Upon Awakening	Baseline and Week 2	Patients were asked to rate the symptom of Nasal Congestion Upon Awakening daily on a 4-point scale (0 (best) to 3 (worst)).
Secondary	Patient's Global Evaluation of Allergic Rhinitis	Week 2	An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

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 Week 2	The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.	Units on a Scale	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline in Nighttime Symptoms Score	Baseline and Week 2	The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.	Units on a Scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms)	Baseline and Week 2	The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.	Units on a Scale	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline in Daytime Eye Symptoms Score	Baseline and Week 2	The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.	Units on a Scale	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline in Daytime Nasal Congestion Score	Baseline and Week 2	The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.	Units on a Scale	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline in Daytime Rhinorrhea Score	Baseline and Week 2	The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.	Units on a Scale	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline in Daytime Nasal Itching Score	Baseline and Week 2	The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.	Units on a Scale	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline in Daytime Sneezing Score	Baseline and Week 2	The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.	Units on a Scale	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline in Nasal Congestion Upon Awakening	Baseline and Week 2	The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.	Units on a Scale	LEAST_SQUARES_MEAN
SECONDARY	Patient's Global Evaluation of Allergic Rhinitis	Week 2	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.	Units on a Scale	LEAST_SQUARES_MEAN

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group48

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	Placebo	-0.26	95% Confidence Interval -0.34 to -0.17	Units on a Scale
Mean Change From Baseline in Daytime Nasal Symptoms Score	Montelukast	-0.48	95% Confidence Interval -0.57 to -0.40	Units on a Scale
Mean Change From Baseline in Daytime Nasal Symptoms Score	Loratadine	-0.52	95% Confidence Interval -0.58 to -0.46	Units on a Scale
Mean Change From Baseline in Daytime Nasal Symptoms Score	Montelukast/Loratadine	-0.58	95% Confidence Interval -0.64 to -0.51	Units on a Scale
Mean Change From Baseline in Nighttime Symptoms Score	Placebo	-0.12	95% Confidence Interval -0.20 to -0.04	Units on a Scale
Mean Change From Baseline in Nighttime Symptoms Score	Montelukast	-0.29	95% Confidence Interval -0.37 to -0.22	Units on a Scale
Mean Change From Baseline in Nighttime Symptoms Score	Loratadine	-0.26	95% Confidence Interval -0.31 to -0.20	Units on a Scale
Mean Change From Baseline in Nighttime Symptoms Score	Montelukast/Loratadine	-0.28	95% Confidence Interval -0.34 to -0.23	Units on a Scale
Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms)	Placebo	-0.2	95% Confidence Interval -0.28 to -0.12	Units on a Scale
Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms)	Montelukast	-0.40	95% Confidence Interval -0.48 to -0.33	Units on a Scale

1 to 10 of 48Source ClinicalTrials.gov

See all 48 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	149
Overall Study	STARTED	Montelukast	155
Overall Study	STARTED	Loratadine	301
Overall Study	STARTED	Montelukast/Loratadine	302
Overall Study	COMPLETED	Placebo	143
Overall Study	COMPLETED	Montelukast	149
Overall Study	COMPLETED	Loratadine	292
Overall Study	COMPLETED	Montelukast/Loratadine	288
Overall Study	NOT COMPLETED	Placebo	6
Overall Study	NOT COMPLETED	Montelukast	6

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events8

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	Headache	Nervous system disorders	Placebo	8	149
other	Headache	Nervous system disorders	Montelukast	5	155
other	Headache	Nervous system disorders	Loratadine	13	301
other	Headache	Nervous system disorders	Montelukast/Loratadine	10	302
serious	Pregnancy	Pregnancy, puerperium and perinatal conditions	Placebo	1	149
serious	Pregnancy	Pregnancy, puerperium and perinatal conditions	Montelukast	0	155
serious	Pregnancy	Pregnancy, puerperium and perinatal conditions	Loratadine	0	301
serious	Pregnancy	Pregnancy, puerperium and perinatal conditions	Montelukast/Loratadine	0	302

Source ClinicalTrials.gov

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Montelukast
Total, all-cause mortality	Loratadine
Total, all-cause mortality	Montelukast/Loratadine
Total, other adverse events	Placebo	8	149
Total, other adverse events	Montelukast	5	155
Total, other adverse events	Loratadine	13	301
Total, other adverse events	Montelukast/Loratadine	10	302
Total, serious adverse events	Placebo	1	149
Total, serious adverse events	Montelukast	0	155

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
12086367	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.

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Read this trial from software.

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