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This study will investigate the effectiveness of desloratadine in treating subjects with allergic rhinitis who meet the criteria for persistent allergic rhinitis (PER)
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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 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Participant's AM/PM PRIOR Total 5 Symptom Score (T5SS) Over Days 1 to 29 of Treatment | AM/PM PRIOR (the participant's status over previous 12 hours) T5SS from the participant's daily diary averaged over treatment Days 1 to 29. AM/PM is the average of separate morning (AM) and evening (PM) evaluations. Scores were defined for T5SS as 0: no symptoms to 15: all severe symptoms. A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference. | Baseline and Days 1-29 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Total Rhinoconjunctivitis Quality of Life Questionnaire-Standarized Version (RQLQ-S) After 29 Days of Treatment | The RQLQ-S was only completed for participants above 18 years of age. The RQLQ-S was not available for participants 12 to 17 years of age. This questionnaire asked questions pertaining to daily activities, sleep, non-nose eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotions. The scale went from 0 (not troubled) to 6 (extremely troubled). A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20559006 | Result | Bousquet J, Bachert C, Canonica GW, Mullol J, Van Cauwenberge P, Jensen CB, Fokkens WJ, Ring J, Keith P, Gopalan G, Lorber R, Zuberbier T; ACCEPT-2 Study Group. Efficacy of desloratadine in persistent allergic rhinitis - a GA(2)LEN study. Int Arch Allergy Immunol. 2010;153(4):395-402. doi: 10.1159/000316351. Epub 2010 Jun 18. | |
| 23676577 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 5-mg Desloratadine Tablet | Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening. |
| FG001 | Placebo Tablet | Matching placebo, orally daily. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 5-mg Desloratadine Tablet | Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening. |
| BG001 | Placebo Tablet | Matching placebo, orally daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change From Baseline in Participant's AM/PM PRIOR Total 5 Symptom Score (T5SS) Over Days 1 to 29 of Treatment | AM/PM PRIOR (the participant's status over previous 12 hours) T5SS from the participant's daily diary averaged over treatment Days 1 to 29. AM/PM is the average of separate morning (AM) and evening (PM) evaluations. Scores were defined for T5SS as 0: no symptoms to 15: all severe symptoms. A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference. | All randomized participants | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Days 1-29 |
|
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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 | Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarction | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (11.0) | 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 |
|---|---|
| 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 tablet | Drug | Placebo tablet, once daily for 12 weeks |
|
| Baseline and Day 29 |
| Change From Baseline in Participant's AM/PM PRIOR T5SS Over Days 1 to 85 of Treatment | AM/PM PRIOR (the participant's status over previous 12 hours) T5SS from the participant's daily diary averaged over treatment Days 1 to 85. AM/PM is the average of separate AM and PM evaluations. Scores were defined for T5SS as 0: no symptoms to 15: all severe symptoms. A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference. | Baseline and Days 1-85 |
| Bousquet J, Zuberbier T, Canonica GW, Fokkens WJ, Gopalan G, Shekar T. Randomized controlled trial of desloratadine for persistent allergic rhinitis: correlations between symptom improvement and quality of life. Allergy Asthma Proc. 2013 May-Jun;34(3):274-82. doi: 10.2500/aap.2013.34.3668. |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Protocol Violation |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Placebo Tablet |
Matching placebo, orally daily. |
|
|
|
| Secondary | Change From Baseline in the Total Rhinoconjunctivitis Quality of Life Questionnaire-Standarized Version (RQLQ-S) After 29 Days of Treatment | The RQLQ-S was only completed for participants above 18 years of age. The RQLQ-S was not available for participants 12 to 17 years of age. This questionnaire asked questions pertaining to daily activities, sleep, non-nose eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotions. The scale went from 0 (not troubled) to 6 (extremely troubled). A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference. | All randomized participants | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Day 29 |
|
|
|
|
| Secondary | Change From Baseline in Participant's AM/PM PRIOR T5SS Over Days 1 to 85 of Treatment | AM/PM PRIOR (the participant's status over previous 12 hours) T5SS from the participant's daily diary averaged over treatment Days 1 to 85. AM/PM is the average of separate AM and PM evaluations. Scores were defined for T5SS as 0: no symptoms to 15: all severe symptoms. A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference. | All randomized participants | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Days 1-85 |
|
|
|
|
| 1 |
| 360 |
| 60 |
| 360 |
| EG001 | Placebo Tablet | Matching placebo, orally daily. | 2 | 356 | 48 | 356 |
| Diverticulum Intestinal | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Lower Limb Fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
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| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |