Trial · NCT00972738
Montelukast in Seasonal Allergic Rhinitis - Spring 2001 Study (0476-235)
NCT00972738, Phase 3, Completed, Organon and Co; results first posted 2010-06-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Montelukast in Seasonal Allergic Rhinitis - Spring 2001 Study (0476-235). Trials, record NCT00972738. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00972738
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Montelukast in Seasonal Allergic Rhinitis - Spring 2001 Study (0476-235)
- NCT number
- NCT00972738
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,214 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- montelukast sodium, Comparator: loratadine, Comparator: Placebo
- First posted
- 2009-09-07
- Last updated
- 2022-02-03
- Results first posted
- 2010-06-16
- Limitations and caveats
In the paper patients who withdrew for worsening allergic rhinitis/conjunctivitis were included under category of discontinued due to lack of efficacy rather than discontinued due to clinical Adverse Events
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 the 2-week Treatment Period | Baseline and over the 2-week treatment period | Mean change from baseline in Daytime Nasal Symptoms. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale \[Score 0 (best) to 3 (worst)\]. 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 Over the 2-week Treatment Period | Baseline and over the 2-week treatment period | Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptoms of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings daily on a 4-point \[Scale 0 (best) to 3 (worst)\]. The average of the individual symptoms scores was reported as the Nighttime Symptoms Score. |
| Secondary | Mean Change From Baseline in Daytime Eye Symptoms Score Over the 2-week Treatment Period | Baseline and over the 2-week treatment period | 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 \[0 (best) to 3 (worst)\]. 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 at the End of the 2-week Treatment Period | End of the 2-week treatment period | An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale \[Score 0 (very much better) to 6 (very much worse)\], of the change in symptoms as compared to the beginning of the study. |
| Secondary | Physician's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period | End of the 2-week treatment period | An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale \[Score 0 (very much better) to 6 (very much worse)\], 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 the 2-week Treatment Period | Baseline and at the end of 2-week treatment period | Patients completed a validated, self-administered Rhinoconjunctivitis Quality-of-Life 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 individual domain scores were calculated as the average values of all scores within a domain, 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 Over the 2-week Treatment Period | Baseline and over the 2-week treatment period | The primary efficacy analyses were based on intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Nighttime Symptoms Score Over the 2-week Treatment Period | Baseline and over the 2-week treatment period | The primary efficacy analyses were based on intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Daytime Eye Symptoms Score Over the 2-week Treatment Period | Baseline and over the 2-week treatment period | The primary efficacy analyses were based on intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Patient's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period | End of the 2-week treatment period | 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. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Physician's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period | End of the 2-week treatment period | 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. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After the 2-week Treatment Period | Baseline and at the end of 2-week treatment period | The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and a week 2 measurement were included. No missing values were imputed. | Scores 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 the 2-week Treatment Period | Montelukast 10 mg | -0.38 | 95% Confidence Interval -0.43 to -0.33 | Scores on a scale | |
| Mean Change From Baseline in Daytime Nasal Symptoms Score Over the 2-week Treatment Period | Loratadine 10 mg | -0.47 | 95% Confidence Interval -0.55 to -0.39 | Scores on a scale | |
| Mean Change From Baseline in Daytime Nasal Symptoms Score Over the 2-week Treatment Period | Placebo | -0.29 | 95% Confidence Interval -0.33 to -0.24 | Scores on a scale | |
| Mean Change From Baseline in Nighttime Symptoms Score Over the 2-week Treatment Period | Montelukast 10 mg | -0.28 | 95% Confidence Interval -0.32 to -0.24 | Scores on a scale | |
| Mean Change From Baseline in Nighttime Symptoms Score Over the 2-week Treatment Period | Loratadine 10 mg | -0.28 | 95% Confidence Interval -0.35 to -0.21 | Scores on a scale | |
| Mean Change From Baseline in Nighttime Symptoms Score Over the 2-week Treatment Period | Placebo | -0.20 | 95% Confidence Interval -0.25 to -0.16 | Scores on a scale | |
| Mean Change From Baseline in Daytime Eye Symptoms Score Over the 2-week Treatment Period | Montelukast 10 mg | -0.28 | 95% Confidence Interval -0.32 to -0.23 | Scores on a scale | |
| Mean Change From Baseline in Daytime Eye Symptoms Score Over the 2-week Treatment Period | Loratadine 10 mg | -0.40 | 95% Confidence Interval -0.47 to -0.32 | Scores on a scale | |
| Mean Change From Baseline in Daytime Eye Symptoms Score Over the 2-week Treatment Period | Placebo | -0.21 | 95% Confidence Interval -0.25 to -0.16 | Scores on a scale | |
| Patient's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period | Montelukast 10 mg | 2.18 | 95% Confidence Interval 2.05 to 2.31 | Scores 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 | Montelukast 10 mg | 522 | |
| Overall Study | STARTED | Loratadine 10 mg | 171 | |
| Overall Study | STARTED | Placebo | 521 | |
| Overall Study | COMPLETED | Montelukast 10 mg | 501 | |
| Overall Study | COMPLETED | Loratadine 10 mg | 165 | |
| Overall Study | COMPLETED | Placebo | 492 | |
| Overall Study | NOT COMPLETED | Montelukast 10 mg | 21 | |
| Overall Study | NOT COMPLETED | Loratadine 10 mg | 6 | |
| Overall Study | NOT COMPLETED | Placebo | 29 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Montelukast 10 mg | ||
| Total, all-cause mortality | Loratadine 10 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Montelukast 10 mg | 0 | 522 |
| Total, other adverse events | Loratadine 10 mg | 0 | 171 |
| Total, other adverse events | Placebo | 0 | 521 |
| Total, serious adverse events | Montelukast 10 mg | 0 | 522 |
| Total, serious adverse events | Loratadine 10 mg | 0 | 171 |
| Total, serious adverse events | Placebo | 0 | 521 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 12602669 | 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/NCT00972738
GET https://conductscience.org/api/trials/v1/NCT00972738/registered