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This study will investigate the effectiveness of desloratadine in treating subjects with allergic rhinitis (AR) who meet the criteria for intermittent allergic rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5-mg Desloratadine tablet | Experimental |
| |
| Placebo tablet | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-mg Desloratadine | Drug | 5-mg Desloratadine tablet, once daily for 15 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Change From Baseline in the 12-hour AM/PM-PRIOR (Reflective) Total 5 Symptom Score (T5SS) From Subject Daily Diaries Averaged Over Treatment Days 1 to 15 | AM/PM is the average of separate morning (AM) and evening (PM) evaluations. T5SS = the sum of the individual scores for nasal congestion/stuffiness, sneezing, rhinorrhea/nasal discharge, nasal pruritis, and ocular pruritis. Each individual symptom/sign was scored from 0 (none) to 3 (severe). | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S) at the Final Visit | The RQLQ-S questionnaire consists of 28 questions grouped into 7 domains. Each question is scored on a scale of 0 (not troubled with symptoms) to 6 (extremely troubled with symptoms). The total RQLQ-S score is the average score of the 28 questions which consisted of a total of 7 domains. |
| Measure | Description | Time Frame |
|---|---|---|
| Total 5 Symptom Score (T5SS) - Average AM/PM PRIOR (Reflective) 12 Hours Diary: BASELINE | AM/PM is the average of separate morning (AM) and evening (PM) evaluations. T5SS = the sum of the individual scores for nasal congestion/stuffiness, sneezing, rhinorrhea/nasal discharge, nasal pruritis, and ocular pruritis. Each individual symptom/sign was scored from 0 (none) to 3 (severe). | Baseline |
Inclusion Criteria:
The subject must meet ALL of the criteria listed below for entry:
Exclusion Criteria:
The subject will be excluded from entry if ANY of the criteria listed below are met:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19624554 | Result | Bousquet J, Bachert C, Canonica GW, Mullol J, Van Cauwenberge P, Bindslev Jensen C, Fokkens WJ, Ring J, Keith P, Lorber R, Zuberbier T; ACCEPT-1 study group. Efficacy of desloratadine in intermittent allergic rhinitis: a GA(2)LEN study. Allergy. 2009 Oct;64(10):1516-1523. doi: 10.1111/j.1398-9995.2009.02115.x. Epub 2009 Jul 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 5-mg Desloratadine Tablet | 5 mg desloratadine tablet, once daily for 15 days |
| FG001 | Placebo Tablet | placebo tablet, once daily for 15 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 5-mg Desloratadine Tablet | 5 mg desloratadine tablet, once daily for 15 days |
| BG001 | Placebo Tablet | placebo tablet, once daily for 15 days |
| 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 | The Change From Baseline in the 12-hour AM/PM-PRIOR (Reflective) Total 5 Symptom Score (T5SS) From Subject Daily Diaries Averaged Over Treatment Days 1 to 15 | AM/PM is the average of separate morning (AM) and evening (PM) evaluations. T5SS = the sum of the individual scores for nasal congestion/stuffiness, sneezing, rhinorrhea/nasal discharge, nasal pruritis, and ocular pruritis. Each individual symptom/sign was scored from 0 (none) to 3 (severe). | Last Observation Carried Forward (LOCF) to the final visit. All randomized subjects with a non-missing baseline and at least some post-baseline data were included in the analyses. | Posted | Least Squares Mean | Standard Error | scores on a scale | 15 days |
|
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Subjects were questioned and/or examined by the investigator for evidence of adverse events. The questioning of subjects with regard to the possible occurrence of adverse events were to be generalized such as, "How have you been feeling since your last visit?"
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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 | 5-mg Desloratadine Tablet | 5 mg desloratadine tablet, once daily for 15 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D012221 | Rhinitis, Allergic, Perennial |
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| C121345 | desloratadine |
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| Placebo | Drug | Placebo tablet, once daily for 15 days |
|
| 15 days |
| Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S: BASELINE | The RQLQ-S questionnaire consists of 28 questions grouped into 7 domains. Each question is scored on a scale of 0 (not troubled with symptoms) to 6 (extremely troubled with symptoms). The total RQLQ-S score is the average score of the 28 questions which consisted of a total of 7 domains. | Baseline |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Protocol Violation |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Placebo Tablet |
placebo tablet, once daily for 15 days |
|
|
|
| Secondary | Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S) at the Final Visit | The RQLQ-S questionnaire consists of 28 questions grouped into 7 domains. Each question is scored on a scale of 0 (not troubled with symptoms) to 6 (extremely troubled with symptoms). The total RQLQ-S score is the average score of the 28 questions which consisted of a total of 7 domains. | Last Observation Carried Forward (LOCF) to the final visit. The RQLQ-S was only completed for subjects >=18 years of age and where available in the local language. | Posted | Least Squares Mean | Standard Error | scores on a scale | 15 days |
|
|
|
|
| Other Pre-specified | Total 5 Symptom Score (T5SS) - Average AM/PM PRIOR (Reflective) 12 Hours Diary: BASELINE | AM/PM is the average of separate morning (AM) and evening (PM) evaluations. T5SS = the sum of the individual scores for nasal congestion/stuffiness, sneezing, rhinorrhea/nasal discharge, nasal pruritis, and ocular pruritis. Each individual symptom/sign was scored from 0 (none) to 3 (severe). | Last Observation Carried Forward (LOCF) to the final visit. All randomized subjects with a non-missing baseline and at least some post-baseline data were included in the analyses. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline |
|
|
|
| Other Pre-specified | Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S: BASELINE | The RQLQ-S questionnaire consists of 28 questions grouped into 7 domains. Each question is scored on a scale of 0 (not troubled with symptoms) to 6 (extremely troubled with symptoms). The total RQLQ-S score is the average score of the 28 questions which consisted of a total of 7 domains. | Last Observation Carried Forward (LOCF) to the final visit. The RQLQ-S was only completed for subjects >=18 years of age and where available in the local language. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline |
|
|
|
| 0 |
| 276 |
| 18 |
| 276 |
| EG001 | Placebo Tablet | placebo tablet, once daily for 15 days | 0 | 271 | 17 | 271 |
PI must provide sponsor w/ review copies of abstracts or manuscripts for publication that report any results of the study, 45 days before submission for publication or presentation. The sponsor shall have the right to review/comment on the material. If the parties disagree about the appropriateness of the material, PI must meet with sponsor's representatives before submission for publication, for the purpose of making good faith efforts to discuss and resolve any issues of disagreement.
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |