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| ID | Type | Description | Link |
|---|---|---|---|
| MK0476-235 | |||
| 2009_658 |
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This study will assess the treatment effect of montelukast versus placebo over a 2 week period in patients with seasonal allergic rhinitis. Loratadine is included in the study as an active comparator.
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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 orally once daily at bedtime for 2 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Daytime Nasal Symptoms Score 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. | Baseline and over the 2-week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Nighttime Symptoms Score 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. |
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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 |
|---|---|---|---|
| 12602669 | Background | van Adelsberg J, Philip G, LaForce CF, Weinstein SF, Menten J, Malice MP, Reiss TF; Montelukast Spring Rhinitis Investigator Group. Randomized controlled trial evaluating the clinical benefit of montelukast for treating spring seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2003 Feb;90(2):214-22. doi: 10.1016/S1081-1206(10)62144-8. |
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Patients who required certain medications as described in the protocol 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.
Thirty-two study sites in Canada and the United States.
Primary Therapy Period: Apr-2001 to Jul-2001.
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| ID | Title | Description |
|---|---|---|
| FG000 | Montelukast 10 mg | Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks. |
| FG001 | Loratadine 10 mg | Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks. |
| FG002 | Placebo | Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Montelukast 10 mg | Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks. |
| BG001 | Loratadine 10 mg | Loratadine 10 mg compressed tablet and montelukast 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 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline and over the 2-week treatment period |
|
During the two week double-blind treatment period , and up to and including 14 days after the last dose of study therapy.
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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 | Montelukast 10 mg | Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks. |
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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
| 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 orally once daily at bedtime for 2 weeks. |
|
| Comparator: Placebo | Drug | placebo tablet orally once daily at bedtime for 2 weeks |
|
| Baseline and over the 2-week treatment period |
| Mean Change From Baseline in Daytime Eye Symptoms Score 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. | Baseline and over the 2-week treatment period |
| Patient's Global Evaluation of Allergic Rhinitis at the 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. | End of the 2-week treatment period |
| Physician's Global Evaluation of Allergic Rhinitis at the 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. | End of the 2-week treatment period |
| Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After the 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. | Baseline and at the end of 2-week treatment period |
| Lost to Follow-up |
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| Lack of Efficacy |
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| Withdrawal by Subject |
|
| Moved |
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| Other |
|
| BG002 | Placebo | Montelukast matching-image placebo tablet and loratadine matching-image placebo 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 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. | Mean | Standard Deviation | Scores on a scale |
|
| 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 [Score 0 (best) to 3 (worst)]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score. | Mean | Standard Deviation | Scores on a scale |
|
| 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. | Mean | Standard Deviation | Scores on a scale |
|
| Rhinoconjunctivitis Quality-of-Life score | Rhinoconjunctivitis Quality-of-Life score Description (see instructions; limit 350 characters) Self-administered questionnaire which included 28 questions on a 7-point scale [0(best) to 6(worst)] across 7 domains : activity, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotions. Scores for each domain were average, then scores for the 7 domains were averaged for overall score. | Mean | Standard Deviation | Scores on a scale |
|
| OG001 | Loratadine 10 mg | Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks. |
| OG002 | Placebo | Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks. |
|
|
| Secondary | Mean Change From Baseline in Nighttime Symptoms Score 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline and over the 2-week treatment period |
|
|
|
| Secondary | Mean Change From Baseline in Daytime Eye Symptoms Score 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline and over the 2-week treatment period |
|
|
|
| Secondary | Patient's Global Evaluation of Allergic Rhinitis at the 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | End of the 2-week treatment period |
|
|
|
| Secondary | Physician's Global Evaluation of Allergic Rhinitis at the 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | End of the 2-week treatment period |
|
|
|
| Secondary | Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After the 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline and at the end of 2-week treatment period |
|
|
|
| 0 |
| 522 |
| 0 |
| 522 |
| EG001 | Loratadine 10 mg | Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks. | 0 | 171 | 0 | 171 |
| EG002 | Placebo | Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks. | 0 | 521 | 0 | 521 |
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 |