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| ID | Type | Description | Link |
|---|---|---|---|
| MK0476A-162 | |||
| 2009_664 |
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This study will evaluate the ability of montelukast to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine and placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | montelukast |
|
| 2 | Experimental | loratadine |
|
| 3 | Placebo Comparator | placebo |
|
| 4 | Experimental | montelukast/loratadine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: montelukast | Drug | 10 mg montelukast tablet given once daily at bedtime for 2 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Daytime Nasal Symptoms Score Over 2 Weeks | Mean change from baseline in 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. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score. Scores were measured as 0 (best) to 3 (worst). | Baseline and Week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks | Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale, and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score. Scores were measured as 0 (best) to 3 (worst). | 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 |
|---|---|---|---|
| 12100048 | Result | Philip G, Malmstrom K, Hampel FC, Weinstein SF, LaForce CF, Ratner PH, Malice MP, Reiss TF; Montelukast Spring Rhinitis Study Group. Montelukast for treating seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled trial performed in the spring. Clin Exp Allergy. 2002 Jul;32(7):1020-8. doi: 10.1046/j.1365-2222.2002.01422.x. |
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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.
Patients were recruited at 50 sites (43 in the US and 7 in Canada).
Primary Therapy Period: March 2000 to July 2000.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks. |
| FG001 | Montelukast 10 mg | Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks. |
| FG002 | Loratadine 10 mg | Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks. |
| FG003 | Montelukast/Loratadine | Montelukast matching-image placebo tablet, loratadine matching-image placebo tablet, and montelukast 10 mg/loratadine 10 mg combination tablet taken orally once daily at bedtime for 2 weeks. During the study, patients in the montelukast/loratadine combination treatment group were discontinued from further participation due to a business decision by the sponsor. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks. |
| BG001 | Montelukast 10 mg |
| 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 2 Weeks | Mean change from baseline in 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. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score. Scores were measured as 0 (best) to 3 (worst). | The primary efficacy analysis was based on the ITT (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 |
|
During the 2 week, double-blind treatment period, and up to and including 14 days (2 weeks) after the last dose of study therapy.
Patients with two or more specific adverse experiences may be counted more than once in different categories, but only once in each category. Thus the count of Specific Other AEs may not add up to the count of Overall Other AEs.
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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 | Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | CRISP dictionary | Non-systematic Assessment |
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Montelukast/loratadine arm was discontinued due to business decision by sponsor to focus development on montelukast monotherapy. There was no efficacy data reported for this treatment arm.
| 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 |
|---|---|
| D017336 | Loratadine |
| ID | Term |
|---|---|
| D003533 | Cyproheptadine |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| Comparator: loratadine |
| Drug |
10 mg loratadine tablet given once daily at bedtime for 2 weeks |
|
| Comparator: placebo | Drug | placebo tablet given once daily at bedtime for 2 weeks |
|
| Comparator: montelukast/loratadine | Drug | montelukast 10-mg/loratadine 10-mg combination tablet taken orally once daily at bedtime for 2 weeks |
|
| Mean Change From Baseline in Daytime Eye Symptoms Score Over 2 Weeks | 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. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score. Scores were measured as 0 (best) to 3 (worst). | Baseline and Week 2 |
| Patient's Global Evaluation of Allergic Rhinitis at Week 2 | An evaluation by the patient, 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. Scores were measured as 0 (best) to 6 (worst). | Week 2 |
| Physician's Global Evaluation of Allergic Rhinitis at Week 2 | 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. Scores were measured as 0 (best) to 6 (worst). | Week 2 |
| Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score at Week 2 | Patients completed the validated, self-administered RQLQ, which included 28 items on a 7-point scale across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Scores for each domain were averaged, then scores for the 7 domains were averaged for the overall score. Scores were measured as 0 (best) to 6 (worst). | Week 2 |
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Noncompliance |
|
| out-of-state |
|
| vacation |
|
| elevated lab values pre-randomization |
|
| Discontinued in Error |
|
| Left Country |
|
| Treatment Group Terminated by Sponsor |
|
Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
| BG002 | Loratadine 10 mg | Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks. |
| BG003 | Montelukast/Loratadine | Montelukast matching-image placebo tablet, loratadine matching-image placebo tablet, and montelukast 10 mg/loratadine 10 mg combination tablet taken orally once daily at bedtime for 2 weeks. During the study, patients in the montelukast/loratadine combination treatment group were discontinued from further participation due to a business decision by the sponsor. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Daytime eye symptoms score | Computed using the average values of the 4 individual daytime eye symptoms scores of tearing, itching, red, and puffy eyes. Scores were measured as 0 (best) to 3 (worst). Baseline is computed as the average daily value during the run-in period. | Mean | Standard Deviation | Units on a Scale |
|
| Daytime nasal symptoms score | Computed using the average values of the 4 individual daytime nasal symptoms scores of congestion, rhinorrhea, itching, and sneezing. Scores were measured as 0 (best) to 3 (worst). Baseline is computed as the average daily value during the run-in period. | Mean | Standard Deviation | Units on a Scale |
|
| Nighttime symptoms score | Computed using the average values of the 3 individual nighttime symptoms scores of nasal congestion upon awakening, difficulty going to sleep, and nighttime awakenings. Scores were measured as 0 (best) to 3 (worst). Baseline is computed as the average daily value during the run-in period. | Mean | Standard Deviation | Units on a Scale |
|
| Rhinoconjunctivitis quality-of-life questionnaire (RQLQ) overall score | Computed by averaging the scores of the 7 domains of activity, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotions. Scores were measured as 0 (best) to 6 (worst). The 7 domains included 28 questions total. The average score was calculated for each domain, then the 7 domains were averaged to obtain the overall score. Baseline is the Visit 3 value. | Mean | Standard Deviation | Units on a Scale |
|
| OG001 | Montelukast 10 mg | Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks. |
| OG002 | Loratadine 10 mg | Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks. |
|
|
| Secondary | Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks | Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale, and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score. Scores were measured as 0 (best) to 3 (worst). | The secondary efficacy analyses were based on the ITT (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 Over 2 Weeks | 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. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score. Scores were measured as 0 (best) to 3 (worst). | The secondary efficacy analyses were based on the ITT (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 at Week 2 | An evaluation by the patient, 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. Scores were measured as 0 (best) to 6 (worst). | This secondary endpoint analysis was performed using the intention-to-treat approach. Patients were excluded if no treatment period data were available. No missing values were imputed. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a Scale | Week 2 |
|
|
|
| Secondary | Physician's Global Evaluation of Allergic Rhinitis at Week 2 | 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. Scores were measured as 0 (best) to 6 (worst). | This secondary endpoint analysis was performed using the intention-to-treat approach. Patients were excluded if no treatment period data were available. 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 Questionnaire (RQLQ) Overall Score at Week 2 | Patients completed the validated, self-administered RQLQ, which included 28 items on a 7-point scale across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Scores for each domain were averaged, then scores for the 7 domains were averaged for the overall score. Scores were measured as 0 (best) to 6 (worst). | This secondary endpoint analysis was performed using the intention-to-treat approach. Patients were excluded if no baseline or treatment period data were available. No missing values were imputed. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a Scale | Week 2 |
|
|
|
| 1 |
| 352 |
| 0 |
| 352 |
| EG001 | Montelukast 10mg | Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks. | 0 | 348 | 0 | 348 |
| EG002 | Loratadine 10mg | Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks. | 0 | 602 | 0 | 602 |
| EG003 | Montelukast 10 mg + Loratadine 10 mg | Montelukast matching-image placebo tablet, loratadine matching-image placebo tablet, and montelukast 10 mg/loratadine 10 mg combination tablet taken orally once daily at bedtime for 2 weeks. During the study, patients in the montelukast/loratadine combination treatment group were discontinued from further participation due to a business decision by the sponsor. | 0 | 275 | 0 | 275 |
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 |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |