Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK0476-265 | |||
| 2004_018 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the effect of an approved medication on the symptoms of perennial allergic rhinitis (an inflammation of the mucous membrane of the nose similar to that found in hay fever except that symptoms persist throughout the year), in patients who have a history of perennial allergic rhinitis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Montelukast |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Montelukast | Drug | one 10 mg tablet, taken once daily at bed time for 6 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Daytime Nasal Symptoms Score Averaged Over the 6-week Treatment Period in Patients With Perennial Allergic Rhinitis | Mean change from baseline in Daytime Nasal Symptoms score averaged over the 6-week treatment period. The Daytime Nasal Symptoms score was calculated as the average of the 3 individual scores for Congestion, Rhinorrhea, and Sneezing, each rated by patients daily on a 4-point scale [Score 0 (best) to 3 (worst)]. | 6 week treatment period (from baseline though the end of week 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's Global Evaluation of Allergic Rhinitis at the End of the 6 Week Treatment Period | An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], in answer to a single question regarding the change in symptoms as compared to the beginning of the study. | At the end of the 6 week treatment period |
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 |
|---|---|---|---|
| 16400895 | Background | Patel P, Philip G, Yang W, Call R, Horak F, LaForce C, Gilles L, Garrett GC, Dass SB, Knorr BA, Reiss TF. Randomized, double-blind, placebo-controlled study of montelukast for treating perennial allergic rhinitis. Ann Allergy Asthma Immunol. 2005 Dec;95(6):551-7. doi: 10.1016/S1081-1206(10)61018-6. |
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.
Patients were screened at 122 sites worldwide.
Primary therapy period: Oct 2003 to May 2004
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks. |
| FG001 | Montelukast 10 mg | Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks. |
| BG001 | Montelukast 10 mg | Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 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 Averaged Over the 6-week Treatment Period in Patients With Perennial Allergic Rhinitis | Mean change from baseline in Daytime Nasal Symptoms score averaged over the 6-week treatment period. The Daytime Nasal Symptoms score was calculated as the average of the 3 individual scores for Congestion, Rhinorrhea, and Sneezing, each rated by patients daily on a 4-point scale [Score 0 (best) to 3 (worst)]. | The primary efficacy analyses were performed using a modified intention-to-treat (MITT) approach. All patients with efficacy measurements, both at baseline and during the treatment period were included. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | 6 week treatment period (from baseline though the end of week 6) |
|
Adverse events (AEs) were collected during the 6 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy.
The number of participants listed in the AE tables (990 placebo & 1002 montelukast) is the number that received treatment.
Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other 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 tablets were taken orally once daily at bedtime for 6 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial Infarction | Cardiac disorders | MedDRA (7.0) | Non-systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| 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: Placebo |
| Drug |
one placebo tablet, taken once daily at bed time for 6 weeks |
|
| Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score After the 6 Week Treatment Period | Patients completed the validated, self-administered RQLQ which included 28 items on a 7-point scale [Score 0 (best) to 6 (worst)] across 7 domains: activities, sleep, nonnose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The scores for each domain were averaged, then scores for the 7 domains were averaged to obtain the overall score. | Baseline and Week 6 |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Other |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Daytime nasal symptoms score | Computed using the average values of the 3 individual daytime nasal symptoms scores of congestion, rhinorrhea, and sneezing on a 4-point scale [Score 0 (best) to 3 (worst)]. Baseline is computed as the average daily value during the prerandomization run-in period (which included the 5-7 days prior to randomization at Visit 3). | Mean | Standard Deviation | Scores on a scale |
|
| Rhinoconjunctivitis Quality-of-Life Score | Patients completed the validated, self-administered RQLQ which included 28 items 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 within each domain were averaged, then the scores for the 7 domains were averaged to obtain the overall score. Baseline is the Visit 3 value. | Mean | Standard Deviation | Score on a scale |
|
| OG001 | Montelukast 10 mg | Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks. |
|
|
| Secondary | Patient's Global Evaluation of Allergic Rhinitis at the End of the 6 Week Treatment Period | An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], in answer to a single question regarding the change in symptoms as compared to the beginning of the study. | The analysis was performed using a modified intention-to-treat (MITT) approach. Patients were excluded if no treatment period data were available. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | At the end of the 6 week treatment period |
|
|
|
| Secondary | Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score After the 6 Week Treatment Period | Patients completed the validated, self-administered RQLQ which included 28 items on a 7-point scale [Score 0 (best) to 6 (worst)] across 7 domains: activities, sleep, nonnose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The scores for each domain were averaged, then scores for the 7 domains were averaged to obtain the overall score. | The primary efficacy analyses were performed using a modified intention-to-treat (MITT) approach. Patients were excluded if no baseline or treatment period data were available | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline and Week 6 |
|
|
|
| 1 |
| 990 |
| 0 |
| 990 |
| EG001 | Montelukast 10 mg | Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks. | 4 | 1,002 | 0 | 1,002 |
| Joint Injury | Injury, poisoning and procedural complications | MedDRA (7.0) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Anxiety Disorder | Psychiatric disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (7.0) | 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 |