Trial · NCT00979901
Montelukast in Patients With Seasonal Allergic Rhinitis - Spring 2000 Study (MK-0476A-162)(COMPLETED)
NCT00979901, Phase 3, Completed, Organon and Co; results first posted 2010-06-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Montelukast in Patients With Seasonal Allergic Rhinitis - Spring 2000 Study (MK-0476A-162)(COMPLETED). Trials, record NCT00979901. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00979901
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Montelukast in Patients With Seasonal Allergic Rhinitis - Spring 2000 Study (MK-0476A-162)(COMPLETED)
- NCT number
- NCT00979901
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,577 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- Comparator: montelukast, Comparator: loratadine, Comparator: placebo, Comparator: montelukast/loratadine
- First posted
- 2009-09-18
- Last updated
- 2022-02-09
- Results first posted
- 2010-06-08
- Limitations and caveats
- Montelukast/loratadine arm was discontinued due to business decision by sponsor to focus development on montelukast monotherapy. There was no efficacy data reported for this treatment arm.
Source ClinicalTrials.gov
Registered outcomes6
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 2 Weeks | 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. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score. Scores were measured as 0 (best) to 3 (worst). |
| Secondary | Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks | 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, and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score. Scores were measured as 0 (best) to 3 (worst). |
| Secondary | Mean Change From Baseline in Daytime Eye Symptoms Score Over 2 Weeks | Baseline and Week 2 | Mean change from baseline in Daytime Eye Symptoms scores. Patients were asked to rate each of the 4 eye symptoms of tearing, itchy, red, and puffy eyes daily on a 4-point scale. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score. Scores were measured as 0 (best) to 3 (worst). |
| Secondary | Patient's Global Evaluation of Allergic Rhinitis at Week 2 | 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. Scores were measured as 0 (best) to 6 (worst). |
| Secondary | Physician's Global Evaluation of Allergic Rhinitis at Week 2 | Week 2 | An evaluation by the physician, 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. Scores were measured as 0 (best) to 6 (worst). |
| Secondary | Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score at Week 2 | Week 2 | Patients completed the validated, self-administered RQLQ, which included 28 items on a 7-point scale across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Scores for each domain were averaged, then scores for the 7 domains were averaged for the overall score. Scores were measured as 0 (best) to 6 (worst). |
Source ClinicalTrials.gov
Outcomes6
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 2 Weeks | Baseline and Week 2 | The primary efficacy analysis was based on the ITT (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 Over 2 Weeks | Baseline and Week 2 | The secondary efficacy analyses were based on the ITT (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 Over 2 Weeks | Baseline and Week 2 | The secondary efficacy analyses were based on the ITT (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 at Week 2 | Week 2 | This secondary endpoint analysis was performed using the intention-to-treat approach. Patients were excluded if no treatment period data were available. No missing values were imputed. | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Physician's Global Evaluation of Allergic Rhinitis at Week 2 | Week 2 | This secondary endpoint analysis was performed using the intention-to-treat approach. Patients were excluded if no treatment period data were available. No missing values were imputed. | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score at Week 2 | Week 2 | This secondary endpoint analysis was performed using the intention-to-treat approach. Patients were excluded if no baseline or treatment period data were available. No missing values were imputed. | Units on a Scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group18
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 2 Weeks | Placebo | -0.24 | 95% Confidence Interval -0.29 to -0.18 | Units on a Scale | |
| Mean Change From Baseline in Daytime Nasal Symptoms Score Over 2 Weeks | Montelukast 10 mg | -0.37 | 95% Confidence Interval -0.43 to -0.31 | Units on a Scale | |
| Mean Change From Baseline in Daytime Nasal Symptoms Score Over 2 Weeks | Loratadine 10 mg | -0.47 | 95% Confidence Interval -0.52 to -0.43 | Units on a Scale | |
| Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks | Placebo | -0.14 | 95% Confidence Interval -0.19 to -0.09 | Units on a Scale | |
| Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks | Montelukast 10 mg | -0.27 | 95% Confidence Interval -0.32 to -0.22 | Units on a Scale | |
| Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks | Loratadine 10 mg | -0.23 | 95% Confidence Interval -0.27 to -0.19 | Units on a Scale | |
| Mean Change From Baseline in Daytime Eye Symptoms Score Over 2 Weeks | Placebo | -0.12 | 95% Confidence Interval -0.17 to -0.06 | Units on a Scale | |
| Mean Change From Baseline in Daytime Eye Symptoms Score Over 2 Weeks | Montelukast 10 mg | -0.26 | 95% Confidence Interval -0.32 to -0.20 | Units on a Scale | |
| Mean Change From Baseline in Daytime Eye Symptoms Score Over 2 Weeks | Loratadine 10 mg | -0.32 | 95% Confidence Interval -0.36 to -0.28 | Units on a Scale | |
| Patient's Global Evaluation of Allergic Rhinitis at Week 2 | Placebo | 2.62 | 95% Confidence Interval 2.46 to 2.79 | Units on a Scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 352 | |
| Overall Study | STARTED | Montelukast 10 mg | 348 | |
| Overall Study | STARTED | Loratadine 10 mg | 602 | |
| Overall Study | STARTED | Montelukast/Loratadine | 275 | |
| Overall Study | COMPLETED | Placebo | 334 | |
| Overall Study | COMPLETED | Montelukast 10 mg | 336 | |
| Overall Study | COMPLETED | Loratadine 10 mg | 573 | |
| Overall Study | COMPLETED | Montelukast/Loratadine | 159 | |
| Overall Study | NOT COMPLETED | Placebo | 18 | |
| Overall Study | NOT COMPLETED | Montelukast 10 mg | 12 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events4
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 |
|---|---|---|---|---|---|---|
| serious | Pregnancy | Pregnancy, puerperium and perinatal conditions | Placebo | 1 | 352 | |
| serious | Pregnancy | Pregnancy, puerperium and perinatal conditions | Montelukast 10mg | 0 | 348 | |
| serious | Pregnancy | Pregnancy, puerperium and perinatal conditions | Loratadine 10mg | 0 | 602 | |
| serious | Pregnancy | Pregnancy, puerperium and perinatal conditions | Montelukast 10 mg + Loratadine 10 mg | 0 | 275 |
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 10mg | ||
| Total, all-cause mortality | Loratadine 10mg | ||
| Total, all-cause mortality | Montelukast 10 mg + Loratadine 10 mg | ||
| Total, other adverse events | Placebo | 0 | 352 |
| Total, other adverse events | Montelukast 10mg | 0 | 348 |
| Total, other adverse events | Loratadine 10mg | 0 | 602 |
| Total, other adverse events | Montelukast 10 mg + Loratadine 10 mg | 0 | 275 |
| Total, serious adverse events | Placebo | 1 | 352 |
| Total, serious adverse events | Montelukast 10mg | 0 | 348 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 12100048 | 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.
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/NCT00979901
GET https://conductscience.org/api/trials/v1/NCT00979901/registered