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| ID | Type | Description | Link |
|---|---|---|---|
| MK0476-192 | |||
| 2009_633 |
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A study of the ability of montelukast to improve signs and symptoms of seasonal allergic rhinitis compared with placebo. Loratadine is included in the study as an active control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | montelukast |
|
| 2 | Active Comparator | loratadine |
|
| 3 | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| montelukast sodium | Drug | montelukast 10 mg tablet, taken orally once daily at bed time for 2 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Daytime Nasal Symptoms Score | 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. | Baseline and Week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Nighttime Symptoms Score | 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. | Baseline and Week 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15049402 | Result | Chervinsky P, Philip G, Malice MP, Bardelas J, Nayak A, Marchal JL, van Adelsberg J, Bousquet J, Tozzi CA, Reiss TF. Montelukast for treating fall allergic rhinitis: effect of pollen exposure in 3 studies. Ann Allergy Asthma Immunol. 2004 Mar;92(3):367-73. doi: 10.1016/S1081-1206(10)61576-1. |
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Patients who required excluded medication and those who did not meet a minimum predefined level of combined daytime nasal symptoms score during the run-in period were excluded from randomization.
Twenty-nine study centers in the United States.
Therapy Period: August 2000 to October 2000
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks |
| FG001 | Montelukast | Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks. |
| FG002 | Loratadine | Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks |
| BG001 | Montelukast | Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline in Daytime Nasal Symptoms Score | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a Scale | Baseline and Week 2 |
|
Over the 2-week treatment period and including 14 days follow-up post-treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | CRISP dictionary | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | CRISP dictionary | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C093875 | montelukast |
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| Comparator: loratadine |
| Drug |
loratadine 10 mg tablet, taken orally once daily at bed time for 2 weeks |
|
| Comparator: placebo | Drug | placebo tablet, taken orally once daily at bed time for 2 weeks |
|
| Mean Change From Baseline in Daytime Eye Symptoms Score |
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. |
| Baseline and Week 2 |
| Patient's Global Evaluation of Allergic Rhinitis | 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). | Week 2 (or upon discontinuation) |
| Physician's Global Evaluation of Allergic Rhinitis | 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). | Week 2 |
| Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score | 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. | Baseline and Week 2 |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG002 | Loratadine | Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Daytime Eye Symptoms score | Patients were asked to rate each eye symptom (tearing, itchy, red, and puffy eyes) daily in the evening on a 4-point scale [0(best) to 3(worst)]. The Daytime Eye Symptoms score is the average of these 4 symptoms. Baseline is computed as average of daily values during the prerandomization run-in period. | Mean | Standard Deviation | Units on a Scale |
|
| Daytime Nasal Symptoms Score | Patients were asked to rate each of 4 nasal symptoms (Congestion, Rhinorrhea, Itching, and Sneezing) daily in the evening on a 4-point scale [0(best) to 3(worst)]. The Daytime Nasal Symptoms Score is the average of these 4 symptoms . Baseline is computed as average of daily values during the prerandomization run-in period (includes the 3 to 5 days prior to Visit 3). | Mean | Standard Deviation | Units on a Scale |
|
| Nighttime Symptoms Score | Patients were asked to rate each symptom (Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings) daily in the morning on a 4-point scale [0(best) to 3(worst)]. The Nighttime Symptoms Score is the average of these 3 symptoms. Baseline is computed as average of daily values during the prerandomization run-in period. | Mean | Standard Deviation | Units on a Scale |
|
| Rhinoconjunctivitis Quality-of-Life score | Patients completed a validated, self-administered Rhinoconjunctivitis Quality-of-Life Questionnaire Scored [0(best) to 3(worst)]. | Mean | Standard Deviation | Units on a Scale |
|
| Montelukast |
Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks. |
| OG002 | Loratadine | Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks. |
|
|
| Secondary | Mean Change From Baseline in Nighttime Symptoms Score | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a Scale | Baseline and Week 2 |
|
|
|
| Secondary | Mean Change From Baseline in Daytime Eye Symptoms Score | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a Scale | Baseline and Week 2 |
|
|
|
| Secondary | Patient's Global Evaluation of Allergic Rhinitis | 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). | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a Scale | Week 2 (or upon discontinuation) |
|
|
|
| Secondary | Physician's Global Evaluation of Allergic Rhinitis | 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). | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a Scale | Week 2 |
|
|
|
| Secondary | Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a Scale | Baseline and Week 2 |
|
|
|
| 0 |
| 333 |
| 19 |
| 333 |
| EG001 | Montelukast | Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks. | 1 | 326 | 13 | 326 |
| EG002 | Loratadine | Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks. | 0 | 170 | 8 | 170 |
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |