Trial · NCT00960141
A Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis (MK-0476-192)(COMPLETED)
NCT00960141, Phase 3, Completed, Organon and Co; results first posted 2010-06-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis (MK-0476-192)(COMPLETED). Trials, record NCT00960141. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00960141
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis (MK-0476-192)(COMPLETED)
- NCT number
- NCT00960141
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 829 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- montelukast sodium, Comparator: loratadine, Comparator: placebo
- First posted
- 2009-08-17
- Last updated
- 2022-02-03
- Results first posted
- 2010-06-09
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 | Baseline and Week 2 | Mean change from baseline in Daytime Nasal Symptoms score on a 4-point scale \[0(best) to 3(worst)\]. The average of the 4 individual nasal symptoms scores (Congestion, Rhinorrhea, Itching, and Sneezing) 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 on a 4-point scale \[0(best) to 3(worst)\]. The average of 3 scores (Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings) was reported as the Nighttime Symptoms Score. |
| Secondary | Mean Change From Baseline in Daytime Eye Symptoms Score | Baseline and Week 2 | Mean change from baseline in Daytime Eye Symptoms scores on a 4-point scale \[0(best) to 3(worst)\]. The average of the 4 individual eye symptoms scores (tearing, itchy, red, and puffy eyes) was reported as the Daytime Eye Symptoms Score. |
| Secondary | Patient's Global Evaluation of Allergic Rhinitis | Week 2 (or upon discontinuation) | An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale, in answer to a single question regarding 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). |
| Secondary | Physician's Global Evaluation of Allergic Rhinitis | 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. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse). |
| Secondary | Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score | Baseline and Week 2 | Patients completed a validated, self-administered questionnaire, which included 28 questions on a 7-point scale \[score 0 (best) to 6 (worst)\] across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The scores for each domain were averaged, then the scores for the 7 domains were averaged for the overall score. |
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 | 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 | 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 | Patient's Global Evaluation of Allergic Rhinitis | Week 2 (or upon discontinuation) | 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. | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Physician's Global Evaluation of Allergic Rhinitis | Week 2 | 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. | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life 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. 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 | Placebo | -0.32 | 95% Confidence Interval -0.37 to -0.26 | Units on a Scale | |
| Mean Change From Baseline in Daytime Nasal Symptoms Score | Montelukast | -0.38 | 95% Confidence Interval -0.44 to -0.32 | Units on a Scale | |
| Mean Change From Baseline in Daytime Nasal Symptoms Score | Loratadine | -0.47 | 95% Confidence Interval -0.55 to -0.39 | Units on a Scale | |
| Mean Change From Baseline in Nighttime Symptoms Score | Placebo | -0.18 | 95% Confidence Interval -0.23 to -0.13 | Units on a Scale | |
| Mean Change From Baseline in Nighttime Symptoms Score | Montelukast | -0.28 | 95% Confidence Interval -0.33 to -0.23 | Units on a Scale | |
| Mean Change From Baseline in Nighttime Symptoms Score | Loratadine | -0.26 | 95% Confidence Interval -0.34 to -0.19 | Units on a Scale | |
| Mean Change From Baseline in Daytime Eye Symptoms Score | Placebo | -0.23 | 95% Confidence Interval -0.28 to -0.17 | Units on a Scale | |
| Mean Change From Baseline in Daytime Eye Symptoms Score | Montelukast | -0.29 | 95% Confidence Interval -0.35 to -0.24 | Units on a Scale | |
| Mean Change From Baseline in Daytime Eye Symptoms Score | Loratadine | -0.35 | 95% Confidence Interval -0.43 to -0.28 | Units on a Scale | |
| Patient's Global Evaluation of Allergic Rhinitis | Placebo | 2.62 | 95% Confidence Interval 2.45 to 2.78 | Units on a Scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 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 | 333 | |
| Overall Study | STARTED | Montelukast | 326 | |
| Overall Study | STARTED | Loratadine | 170 | |
| Overall Study | COMPLETED | Placebo | 323 | |
| Overall Study | COMPLETED | Montelukast | 309 | |
| Overall Study | COMPLETED | Loratadine | 163 | |
| Overall Study | NOT COMPLETED | Placebo | 10 | |
| Overall Study | NOT COMPLETED | Montelukast | 17 | |
| Overall Study | NOT COMPLETED | Loratadine | 7 |
Source ClinicalTrials.gov
Adverse events6
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 | 19 | 333 | |
| other | Headache | Nervous system disorders | Montelukast | 13 | 326 | |
| other | Headache | Nervous system disorders | Loratadine | 8 | 170 | |
| serious | Depression | Psychiatric disorders | Placebo | 0 | 333 | |
| serious | Depression | Psychiatric disorders | Montelukast | 1 | 326 | |
| serious | Depression | Psychiatric disorders | Loratadine | 0 | 170 |
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 | 19 | 333 |
| Total, other adverse events | Montelukast | 13 | 326 |
| Total, other adverse events | Loratadine | 8 | 170 |
| Total, serious adverse events | Placebo | 0 | 333 |
| Total, serious adverse events | Montelukast | 1 | 326 |
| Total, serious adverse events | Loratadine | 0 | 170 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 15049402 | 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/NCT00960141
GET https://conductscience.org/api/trials/v1/NCT00960141/registered