Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK0476-240 | |||
| 2009_647 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a study to evaluate the treatment effect of montelukast 10 mg taken in the morning, versus placebo, in patients with seasonal allergic rhinitis. Loratadine is included in the study as an active control.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 in the morning for 4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Daytime Nasal Symptoms Score Over First 2 Weeks of Treatment Period | Mean change from baseline in Daytime Nasal Symptoms Score. Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4- point scale [Score 0 (best) to 3 (worse)]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score. | Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Nighttime Symptoms Score Over First 2 Weeks of Treatment Period | Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale [Score 0 (best) to 3 (worse)], and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14616102 | Background | van Adelsberg J, Philip G, Pedinoff AJ, Meltzer EO, Ratner PH, Menten J, Reiss TF; Montelukast Fall Rhinitis Study Group. Montelukast improves symptoms of seasonal allergic rhinitis over a 4-week treatment period. Allergy. 2003 Dec;58(12):1268-76. doi: 10.1046/j.1398-9995.2003.00261.x. |
Not provided
Not provided
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.
Forty-seven study centers in the United States.
Prime Therapy Period: August 2001 to November 2001
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks |
| FG001 | Montelukast | Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks |
| FG002 | Loratadine | Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks |
| BG001 | Montelukast | Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 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 First 2 Weeks of Treatment Period | Mean change from baseline in Daytime Nasal Symptoms Score. Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4- point scale [Score 0 (best) to 3 (worse)]. The average of the 4 individual nasal symptoms scores 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 through the first 2 weeks of treatment were included. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) |
|
During the 4 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy.
The number of patients listed in the Adverse Event (AE) tables (448 montelukast group, 180 loratadine group and 451 in placebo group) is the number of patients who received study treatment.
Although a patient may have had two or more clinical AEs the patient is counted only once in a category. The same patient may appear in different categories.
Not provided
| 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 placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Gastrointestinal disorders | MERCK CRISP Dict. | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MERCK CRISP Dict. | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
Not provided
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C093875 | montelukast |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Comparator: loratadine |
| Drug |
loratadine 10 mg tablet orally once daily in the morning for 4 weeks |
|
| Comparator: placebo | Drug | placebo tablet orally once daily in the morning for 4 weeks |
|
| Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) |
| Mean Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period | Composite Symptoms Scores were computed as the average of Daytime Nasal Scores [Score 0 (best) to 3 (worst)] and Nighttime Symptoms Scores [Score 0 (best) to 3 (worst)]. | Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) |
| Mean Change From Baseline in Daytime Eye Symptoms Score Over First 2 Weeks of Treatment Period | Mean change from baseline in Daytime Eye Symptoms scores. Patients were asked to rate each of the 4 eye symptom of tearing, itchy, red, and puffy eyes daily on a 4-point scale [Score 0 (best) to 3 (worst)]. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score. | Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) |
| Patient's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment | An evaluation by the patient, administered after the first 2 weeks of treatment using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study. | After first 2 weeks of treatment |
| Physician's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment | An evaluation by the physician, administered after the first 2 weeks of treatment using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study. | After first 2 weeks of treatment |
| Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After First 2 Weeks of Treatment Period | Patients completed a Rhinoconjunctivitis Quality-of-Life Questionnaire-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. The scores for each domain were averaged, then scores for the 7 domains were averaged for an overall score. | Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Pre-randomization Adverse Event |
|
| Moved |
|
| Site closed (local pollen Season ended) |
|
| BG002 | Loratadine | Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Composite Symptoms Score | Composite Symptoms Scores were computed as the average of Daytime Nasal Scores (Score 0 (best) to 3 (worst)) and Nighttime Symptoms Scores [Score 0 (best) to 3 (worst)]. | Mean | Standard Deviation | Scores on a scale |
|
| Daytime Eye Symptoms score | 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 [Score 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 | Daytime Nasal Symptoms Score. Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale [Score 0 (best) to 3 (worse)]. 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 | Nighttime Symptoms Score. Patients were asked to rate each symptom of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings daily on a 4-point scale [Score 0 (best) to 3 (worse)], and the average score of the 3 symptoms was reported as the Nighttime Symptoms Score. | Mean | Standard Deviation | Scores on a scale |
|
| Rhinoconjunctivitis Quality of Life Score | Patients completed a Rhinoconjunctivitis Quality-of-Life Questionnaire-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. The scores for each domain were averaged, then scores for the 7 domains were averaged for an overall score. | Mean | Standard Deviation | Scores on a scale |
|
| OG001 | Montelukast | Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks |
| OG002 | Loratadine | Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks |
|
|
| Secondary | Mean Change From Baseline in Nighttime Symptoms Score Over First 2 Weeks of Treatment Period | Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale [Score 0 (best) to 3 (worse)], and the combined score of 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 through the first 2 weeks of treatment were included | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) |
|
|
|
| Secondary | Mean Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period | Composite Symptoms Scores were computed as the average of Daytime Nasal Scores [Score 0 (best) to 3 (worst)] and Nighttime Symptoms Scores [Score 0 (best) to 3 (worst)]. | 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 through the first 2 weeks of treatment were included | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) |
|
|
|
| Secondary | Mean Change From Baseline in Daytime Eye Symptoms Score Over First 2 Weeks of Treatment Period | Mean change from baseline in Daytime Eye Symptoms scores. Patients were asked to rate each of the 4 eye symptom of tearing, itchy, red, and puffy eyes daily on a 4-point scale [Score 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 the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement through the first 2 weeks of treatment were included | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) |
|
|
|
| Secondary | Patient's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment | An evaluation by the patient, administered after the first 2 weeks of treatment using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study. | 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 | Scores on a scale | After first 2 weeks of treatment |
|
|
|
| Secondary | Physician's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment | An evaluation by the physician, administered after the first 2 weeks of treatment using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study. | 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 | Scores on a scale | After first 2 weeks of treatment |
|
|
|
| Secondary | Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After First 2 Weeks of Treatment Period | Patients completed a Rhinoconjunctivitis Quality-of-Life Questionnaire-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. The scores for each domain were averaged, then scores for the 7 domains were averaged for an 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 through the first 2 weeks of treatment were included | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) |
|
|
|
| 0 |
| 451 |
| 22 |
| 451 |
| EG001 | Montelukast | Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks | 2 | 448 | 27 | 448 |
| EG002 | Loratadine | Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks | 0 | 180 | 12 | 180 |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MERCK CRISP Dict. | Non-systematic Assessment |
|
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 |