Trial · NCT00092118
The Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis (0476-265)
NCT00092118, Phase 3, Completed, Organon and Co; results first posted 2010-07-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis (0476-265). Trials, record NCT00092118. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00092118
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis (0476-265)
- NCT number
- NCT00092118
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,992 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Rhinitis, Allergic, Perennial
- Interventions
- Montelukast, Comparator: Placebo
- First posted
- 2004-09-24
- Last updated
- 2022-02-03
- Results first posted
- 2010-07-23
Source ClinicalTrials.gov
Registered outcomes3
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 Averaged Over the 6-week Treatment Period in Patients With Perennial Allergic Rhinitis | 6 week treatment period (from baseline though the end of week 6) | Mean change from baseline in Daytime Nasal Symptoms score averaged over the 6-week treatment period. The Daytime Nasal Symptoms score was calculated as the average of the 3 individual scores for Congestion, Rhinorrhea, and Sneezing, each rated by patients daily on a 4-point scale \[Score 0 (best) to 3 (worst)\]. |
| Secondary | Patient's Global Evaluation of Allergic Rhinitis at the End of the 6 Week Treatment Period | At the end of the 6 week treatment period | An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale \[Score 0 (best) to 6 (worst)\], in answer to a single question regarding the change in symptoms as compared to the beginning of the study. |
| Secondary | Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score After the 6 Week Treatment Period | Baseline and Week 6 | Patients completed the validated, self-administered RQLQ which included 28 items on a 7-point scale \[Score 0 (best) to 6 (worst)\] across 7 domains: activities, sleep, nonnose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The scores for each domain were averaged, then scores for the 7 domains were averaged to obtain the overall score. |
Source ClinicalTrials.gov
Outcomes3
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 Averaged Over the 6-week Treatment Period in Patients With Perennial Allergic Rhinitis | 6 week treatment period (from baseline though the end of week 6) | The primary efficacy analyses were performed using a modified intention-to-treat (MITT) approach. All patients with efficacy measurements, both at baseline and during the treatment period were included. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Patient's Global Evaluation of Allergic Rhinitis at the End of the 6 Week Treatment Period | At the end of the 6 week treatment period | The analysis was performed using a modified intention-to-treat (MITT) approach. Patients were excluded if no treatment period data were available. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score After the 6 Week Treatment Period | Baseline and Week 6 | The primary efficacy analyses were performed using a modified intention-to-treat (MITT) approach. Patients were excluded if no baseline or treatment period data were available | Score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group6
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 Averaged Over the 6-week Treatment Period in Patients With Perennial Allergic Rhinitis | Placebo | -0.37 | 95% Confidence Interval -0.40 to -0.34 | Score on a scale | |
| Mean Change From Baseline in Daytime Nasal Symptoms Score Averaged Over the 6-week Treatment Period in Patients With Perennial Allergic Rhinitis | Montelukast 10 mg | -0.44 | 95% Confidence Interval -0.48 to -0.41 | Score on a scale | |
| Patient's Global Evaluation of Allergic Rhinitis at the End of the 6 Week Treatment Period | Placebo | 2.42 | 95% Confidence Interval 2.33 to 2.51 | Score on a scale | |
| Patient's Global Evaluation of Allergic Rhinitis at the End of the 6 Week Treatment Period | Montelukast 10 mg | 2.27 | 95% Confidence Interval 2.18 to 2.35 | Score on a scale | |
| Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score After the 6 Week Treatment Period | Placebo | -0.69 | 95% Confidence Interval -0.76 to -0.62 | Score on a scale | |
| Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score After the 6 Week Treatment Period | Montelukast 10 mg | -0.84 | 95% Confidence Interval -0.91 to -0.77 | Score on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 990 | |
| Overall Study | STARTED | Montelukast 10 mg | 1,002 | |
| Overall Study | COMPLETED | Placebo | 906 | |
| Overall Study | COMPLETED | Montelukast 10 mg | 913 | |
| Overall Study | NOT COMPLETED | Placebo | 84 | |
| Overall Study | NOT COMPLETED | Montelukast 10 mg | 89 |
Source ClinicalTrials.gov
Adverse events10
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 | Myocardial Infarction | Cardiac disorders | Placebo | 1 | 990 | |
| serious | Myocardial Infarction | Cardiac disorders | Montelukast 10 mg | 0 | 1,002 | |
| serious | Joint Injury | Injury, poisoning and procedural complications | Placebo | 0 | 990 | |
| serious | Joint Injury | Injury, poisoning and procedural complications | Montelukast 10 mg | 1 | 1,002 | |
| serious | Dehydration | Metabolism and nutrition disorders | Placebo | 0 | 990 | |
| serious | Dehydration | Metabolism and nutrition disorders | Montelukast 10 mg | 1 | 1,002 | |
| serious | Anxiety Disorder | Psychiatric disorders | Placebo | 0 | 990 | |
| serious | Anxiety Disorder | Psychiatric disorders | Montelukast 10 mg | 1 | 1,002 | |
| serious | Asthma | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 990 | |
| serious | Asthma | Respiratory, thoracic and mediastinal disorders | Montelukast 10 mg | 1 | 1,002 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Montelukast 10 mg | ||
| Total, other adverse events | Placebo | 0 | 990 |
| Total, other adverse events | Montelukast 10 mg | 0 | 1,002 |
| Total, serious adverse events | Placebo | 1 | 990 |
| Total, serious adverse events | Montelukast 10 mg | 4 | 1,002 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 16400895 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Montelukast 10 mg vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT00092118
GET https://conductscience.org/api/trials/v1/NCT00092118/registered