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| ID | Type | Description | Link |
|---|---|---|---|
| MK0476A-117 | |||
| 2009_645 |
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This study will evaluate the ability of oral montelukast/loratadine to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine alone, montelukast alone and placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | montelukast/loratadine |
|
| 2 | Experimental | loratadine |
|
| 3 | Experimental | montelukast |
|
| 4 | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: montelukast/loratadine | Drug | montelukast 10 mg/loratadine 10 mg tablet taken 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. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale (0 (best) to 3 (worst)). The average of the 4 individual nasal symptoms scores 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. Patients were asked to rate each symptom daily on a 4-point scale (0 (best) to 3 (worst)), and the combined score of 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 |
|---|---|---|---|
| 12086367 | Result | Nayak AS, Philip G, Lu S, Malice MP, Reiss TF; Montelukast Fall Rhinitis Investigator Group. Efficacy and tolerability of montelukast alone or in combination with loratadine in seasonal allergic rhinitis: a multicenter, randomized, double-blind, placebo-controlled trial performed in the fall. Ann Allergy Asthma Immunol. 2002 Jun;88(6):592-600. doi: 10.1016/S1081-1206(10)61891-1. |
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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.
Forty study centers in the United States.
Therapy Period: September 1999 to November 1999
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks |
| FG001 | Montelukast | Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks |
| FG002 | Loratadine | Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks |
| FG003 | Montelukast/Loratadine | Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks |
| 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 orally once daily at bedtime for 2 weeks |
| BG001 | Montelukast |
| 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. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale (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 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 |
|
During the 2 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy.
Although a patient may have had two or more adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
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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 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 | Pregnancies are not considered serious adverse events, however, they are collected in a similar manner so that they are learned of quickly and are followed to outcome. Therefore they appear as an event in our SAE reporting tables. |
| 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 |
|---|---|
| D017336 | Loratadine |
| ID | Term |
|---|---|
| D003533 | Cyproheptadine |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| Comparator: montelukast | Drug | montelukast 10 mg tablet taken once daily at bed time for 2 weeks |
|
| Comparator: loratadine | Drug | loratadine 10 mg tablet taken once daily at bed time for 2 weeks |
|
| Comparator: placebo | Drug | placebo tablet taken once daily at bed time for 2 weeks |
|
| Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) | Composite Symptoms scores were computed as the average of the Daytime Nasal Symptoms scores and Nighttime Symptoms scores collected on a 4 point scale (0 (best) to 3 (worst)). | Baseline and Week 2 |
| Mean Change From Baseline in Daytime Eye Symptoms Score | 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 (0 (best) to 3 (worst)). The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score. | Baseline and Week 2 |
| Mean Change From Baseline in Daytime Nasal Congestion Score | Patients were asked to rate the nasal symptom of Congestion daily on a 4-point scale (0 (best) to 3 (worst)). | Baseline and Week 2 |
| Mean Change From Baseline in Daytime Rhinorrhea Score | Patients were asked to rate the nasal symptom of Rhinorrhea daily on a 4-point scale (0 (best) to 3 (worst)). | Baseline and Week 2 |
| Mean Change From Baseline in Daytime Nasal Itching Score | Patients were asked to rate the nasal symptom of Nasal Itching daily on a 4-point scale (0 (best) to 3 (worst)). | Baseline and Week 2 |
| Mean Change From Baseline in Daytime Sneezing Score | Patients were asked to rate the nasal symptom of Sneezing daily on a 4-point scale (0 (best) to 3 (worst)). | Baseline and Week 2 |
| Mean Change From Baseline in Nasal Congestion Upon Awakening | Patients were asked to rate the symptom of Nasal Congestion Upon Awakening daily on a 4-point scale (0 (best) to 3 (worst)). | 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, 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 |
| 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 Rhinoconjunctivitis Quality-of-Life Questionnaire, 28 questions on a 7-point scale [0(best) to 6(worst)] across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, emotional. Scores per domain were averaged, then scores for the 7 domains were averaged for an overall score. | Week 2 |
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
| BG002 | Loratadine | Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks |
| BG003 | Montelukast/Loratadine | Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) | 0 (best) to 3 (worst) point scale | Mean | Standard Deviation | Units on a Scale |
|
| Daytime Congestion score | 0 (best) to 3 (worst) point scale | Mean | Standard Deviation | Units on a Scale |
|
| Daytime Eye Symptoms Score | 0 (best) to 3 (worst) point scale | Mean | Standard Deviation | Units on a Scale |
|
| Daytime Nasal Itching score | 0 (best) to 3 (worst) point scale | Mean | Standard Deviation | Units on a Scale |
|
| Daytime Nasal Symptoms Score | 0 (best) to 3 (worst) point scale | Mean | Standard Deviation | Units on a Scale |
|
| Daytime Rhinorrhea score | 0 (best) to 3 (worst) point scale | Mean | Standard Deviation | Units on a Scale |
|
| Daytime Sneezing score | 0 (best) to 3 (worst) point scale | Mean | Standard Deviation | Units on a Scale |
|
| Nasal Congestion Upon Awakening | 0 (best) to 3 (worst) point scale | Mean | Standard Deviation | Units on a Scale |
|
| Nighttime Symptoms Score | 0 (best) to 3 (worst) point scale | Mean | Standard Deviation | Units on a Scale |
|
| Rhinoconjunctivitis Quality-of-Life Score | 0 (best) to 6 (worst) point scale | Mean | Standard Deviation | Units on a Scale |
|
| OG001 | Montelukast | Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks |
| OG002 | Loratadine | Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks |
| OG003 | Montelukast/Loratadine | Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine 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. Patients were asked to rate each symptom daily on a 4-point scale (0 (best) to 3 (worst)), 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 were included. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a Scale | Baseline and Week 2 |
|
|
|
| Secondary | Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) | Composite Symptoms scores were computed as the average of the Daytime Nasal Symptoms scores and Nighttime Symptoms scores collected on a 4 point scale (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 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. Patients were asked to rate each of the 4 eye symptom 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 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 Nasal Congestion Score | Patients were asked to rate the nasal symptom of Congestion daily on a 4-point scale (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 were included. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a Scale | Baseline and Week 2 |
|
|
|
| Secondary | Mean Change From Baseline in Daytime Rhinorrhea Score | Patients were asked to rate the nasal symptom of Rhinorrhea daily on a 4-point scale (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 were included. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a Scale | Baseline and Week 2 |
|
|
|
| Secondary | Mean Change From Baseline in Daytime Nasal Itching Score | Patients were asked to rate the nasal symptom of Nasal Itching daily on a 4-point scale (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 were included. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a Scale | Baseline and Week 2 |
|
|
|
| Secondary | Mean Change From Baseline in Daytime Sneezing Score | Patients were asked to rate the nasal symptom of Sneezing daily on a 4-point scale (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 were included. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a Scale | Baseline and Week 2 |
|
|
|
| Secondary | Mean Change From Baseline in Nasal Congestion Upon Awakening | Patients were asked to rate the symptom of Nasal Congestion Upon Awakening daily on a 4-point scale (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 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, 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 (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 | Units on a Scale | Week 2 |
|
|
|
| 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 (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 | Units on a Scale | Week 2 |
|
|
|
| Secondary | Mean Change From Baseline in 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: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, emotional. Scores per 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 were included. No missing values were imputed. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a Scale | Week 2 |
|
|
|
| 1 |
| 149 |
| 8 |
| 149 |
| EG001 | Montelukast | Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks | 0 | 155 | 5 | 155 |
| EG002 | Loratadine | Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks | 0 | 301 | 13 | 301 |
| EG003 | Montelukast/Loratadine | Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks | 0 | 302 | 10 | 302 |
|
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 |