Trial · NCT00963469
Montelukast in Seasonal Allergic Rhinitis: Fall 2001 Study (0476-240)
NCT00963469, Phase 3, Completed, Organon and Co; results first posted 2010-06-09
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ConductScience Library. Montelukast in Seasonal Allergic Rhinitis: Fall 2001 Study (0476-240). Trials, record NCT00963469. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00963469
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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 2001 Study (0476-240)
- NCT number
- NCT00963469
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,079 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- montelukast sodium, Comparator: loratadine, Comparator: placebo
- First posted
- 2009-08-21
- Last updated
- 2022-02-03
- Results first posted
- 2010-06-09
Source ClinicalTrials.gov
Registered outcomes7
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 Over First 2 Weeks of Treatment Period | Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) | 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 \[Score 0 (best) to 3 (worse)\]. 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 Over First 2 Weeks of Treatment Period | Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) | Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale \[Score 0 (best) to 3 (worse)\], and the combined 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 (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period | Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) | Composite Symptoms Scores were computed as the average of Daytime Nasal Scores \[Score 0 (best) to 3 (worst)\] and Nighttime Symptoms Scores \[Score 0 (best) to 3 (worst)\]. |
| Secondary | Mean Change From Baseline in Daytime Eye Symptoms Score Over First 2 Weeks of Treatment Period | Baseline and first 2 Weeks of treatment period (from randomization through the end of 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 \[Score 0 (best) to 3 (worst)\]. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score. |
| Secondary | Patient's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment | After first 2 weeks of treatment | An evaluation by the patient, administered after the first 2 weeks of treatment 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 After First 2 Weeks of Treatment | After first 2 weeks of treatment | An evaluation by the physician, administered after the first 2 weeks of treatment 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 | Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After First 2 Weeks of Treatment Period | Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) | Patients completed a Rhinoconjunctivitis Quality-of-Life Questionnaire-28 questions on a 7-point scale \[0(best) to 6(worst)\] across 7 domains: activity,sleep,non-nose/eye symptoms,practical problems,nasal symptoms, eye symptoms, and emotions. The scores for each domain were averaged, then scores for the 7 domains were averaged for an overall score. |
Source ClinicalTrials.gov
Outcomes7
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 Over First 2 Weeks of Treatment Period | Baseline and first 2 Weeks of treatment period (from randomization through the end of 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 through the first 2 weeks of treatment were included. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Nighttime Symptoms Score Over First 2 Weeks of Treatment Period | Baseline and first 2 Weeks of treatment period (from randomization through the end of 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 through the first 2 weeks of treatment were included | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period | Baseline and first 2 Weeks of treatment period (from randomization through the end of 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 through the first 2 weeks of treatment were included | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Daytime Eye Symptoms Score Over First 2 Weeks of Treatment Period | Baseline and first 2 Weeks of treatment period (from randomization through the end of 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 through the first 2 weeks of treatment were included | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Patient's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment | After first 2 weeks of treatment | The primary efficacy analyses were based on the intention-to-treat. 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 After First 2 Weeks of Treatment | After first 2 weeks of treatment | The primary efficacy analyses were based on the intention-to-treat. Since only 1 measurement was obtained during the treatment period, no missing values were imputed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After First 2 Weeks of Treatment Period | Baseline and first 2 Weeks of treatment period (from randomization through the end of 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 through the first 2 weeks of treatment were included | Scores on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in Daytime Nasal Symptoms Score Over First 2 Weeks of Treatment Period | Placebo | -0.23 | 95% Confidence Interval -0.28 to -0.18 | Scores on a scale | |
| Mean Change From Baseline in Daytime Nasal Symptoms Score Over First 2 Weeks of Treatment Period | Montelukast | -0.33 | 95% Confidence Interval -0.37 to -0.28 | Scores on a scale | |
| Mean Change From Baseline in Daytime Nasal Symptoms Score Over First 2 Weeks of Treatment Period | Loratadine | -0.45 | 95% Confidence Interval -0.52 to -0.37 | Scores on a scale | |
| Mean Change From Baseline in Nighttime Symptoms Score Over First 2 Weeks of Treatment Period | Placebo | -0.18 | 95% Confidence Interval -0.23 to -0.14 | Scores on a scale | |
| Mean Change From Baseline in Nighttime Symptoms Score Over First 2 Weeks of Treatment Period | Montelukast | -0.28 | 95% Confidence Interval -0.32 to -0.23 | Scores on a scale | |
| Mean Change From Baseline in Nighttime Symptoms Score Over First 2 Weeks of Treatment Period | Loratadine | -0.25 | 95% Confidence Interval -0.32 to -0.19 | Scores on a scale | |
| Mean Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period | Placebo | -0.21 | 95% Confidence Interval -0.25 to -0.16 | Scores on a scale | |
| Mean Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period | Montelukast | -0.30 | 95% Confidence Interval -0.35 to -0.26 | Scores on a scale | |
| Mean Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period | Loratadine | -0.36 | 95% Confidence Interval -0.43 to -0.30 | Scores on a scale | |
| Mean Change From Baseline in Daytime Eye Symptoms Score Over First 2 Weeks of Treatment Period | Placebo | -0.18 | 95% Confidence Interval -0.23 to -0.14 | Scores on a scale |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 451 | |
| Overall Study | STARTED | Montelukast | 448 | |
| Overall Study | STARTED | Loratadine | 180 | |
| Overall Study | COMPLETED | Placebo | 410 | |
| Overall Study | COMPLETED | Montelukast | 420 | |
| Overall Study | COMPLETED | Loratadine | 170 | |
| Overall Study | NOT COMPLETED | Placebo | 41 | |
| Overall Study | NOT COMPLETED | Montelukast | 28 | |
| Overall Study | NOT COMPLETED | Loratadine | 10 |
Source ClinicalTrials.gov
Adverse events9
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 | Headache | Nervous system disorders | Placebo | 22 | 451 | |
| other | Headache | Nervous system disorders | Montelukast | 27 | 448 | |
| other | Headache | Nervous system disorders | Loratadine | 12 | 180 | |
| serious | Appendicitis | Gastrointestinal disorders | Placebo | 0 | 451 | |
| serious | Appendicitis | Gastrointestinal disorders | Montelukast | 1 | 448 | |
| serious | Appendicitis | Gastrointestinal disorders | Loratadine | 0 | 180 | |
| serious | Pregnancy | Pregnancy, puerperium and perinatal conditions | Placebo | 0 | 451 | |
| serious | Pregnancy | Pregnancy, puerperium and perinatal conditions | Montelukast | 1 | 448 | |
| serious | Pregnancy | Pregnancy, puerperium and perinatal conditions | Loratadine | 0 | 180 |
Source ClinicalTrials.gov
Adverse event totals9
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, other adverse events | Placebo | 22 | 451 |
| Total, other adverse events | Montelukast | 27 | 448 |
| Total, other adverse events | Loratadine | 12 | 180 |
| Total, serious adverse events | Placebo | 0 | 451 |
| Total, serious adverse events | Montelukast | 2 | 448 |
| Total, serious adverse events | Loratadine | 0 | 180 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 14616102 | BACKGROUND |
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.
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/NCT00963469
GET https://conductscience.org/api/trials/v1/NCT00963469/results?page=2