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| ID | Type | Description | Link |
|---|---|---|---|
| 152861 | Registry Identifier | JAPIC-CTI | |
| MK-4117-204 | Other Identifier | Merck Registration Number |
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This is an efficacy and safety study of desloratadine (MK-4117) in Japanese participants with seasonal allergic rhinitis (SAR). The primary hypothesis of this study is that the change from Baseline in Total Nasal Symptom Score (TNSS) is improved by desloratadine compared to placebo.
This study consists of a one-week Symptom Confirmation Period during which participants undergo a single-blinded placebo run-in, a two-week double-blind Treatment Period and a two-week Follow-up Period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desloratadine | Experimental | After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) orally (PO) once daily (QD) in the morning for 2 weeks during the Treatment Period. |
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| Placebo | Placebo Comparator | After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desloratadine 5 mg | Drug | Desloratadine 5 mg tablets |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Nasal Symptom Score (TNSS) During 2 Weeks of Therapy | The TNSS was used to evaluate participant nasal symptoms of: sneezing (daily frequency of attacks scored from 0 [<1 time or "none"] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or "none"] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose) as rated in the participant's diary. The TNSS was the sum of the 4 nasal symptom sub-scores. TNSS scores ranged from 0 to 16, with a higher score indicating more frequent/severe nasal symptoms. Baseline (BL) measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement was an average from Day 1 to Day 13 (2 week average). Change from BL = Post BL measurement - BL measurement.](streamdown:incomplete-link) | Baseline, Day 1 to Day 13 (Weeks 1 through 2 average) of double-blind treatment |
| Number of Participants Who Experience at Least One Adverse Event (AE) | An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE. | Up to 4 weeks (Up to 2 weeks after last dose of study drug) |
| Number of Participants Who Discontinue Study Drug Due to an AE | An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in TNSS for Week 1 and Week 2 of Double-blind Treatment | The TNSS was used to evaluate participant nasal symptoms of: sneezing (daily frequency of attacks scored from 0 [<1 time or "none"] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or "none"] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose) as rated in the participant's diary. The TNSS was the sum of the 4 nasal symptom sub-scores. TNSS scores ranged from 0 to 16, with a higher score indicating more frequent/severe nasal symptoms. Baseline (BL) measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement for Week 1 was an average from Day 1 to Day 7 and post-BL measurement for Week 2 was an average from Day 8 to Day 13. Change from BL = Post BL measurement - BL measurement.](streamdown:incomplete-link) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Okubo K, Maeda Y, Oshima N, Hisada S. A Phase III clinical trial of desloratadine in Japanese subjects with seasonal allergic rhinitis: A randomized controlled trial. Arerugi. 2016;32(11):863-876.. [in Japanese] https://mol.medicalonline.jp/archive/search?jo=an9cltmd&ye=2016&vo=32&issue=11 |
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Of 1148 participants screened, 449 were enrolled in the study and randomized to oral (PO) once daily (QD) Desloratadine (n=224) or Placebo (n=225). One participant randomized to Desloratadine was not treated due to withdrawn consent.
Participants with seasonal allergic rhinitis (SAR) were recruited at 3 study sites in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Desloratadine | After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period. |
| FG001 | Placebo | After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All Randomized Participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Desloratadine | After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Change From Baseline in Total Nasal Symptom Score (TNSS) During 2 Weeks of Therapy | The TNSS was used to evaluate participant nasal symptoms of: sneezing (daily frequency of attacks scored from 0 [<1 time or "none"] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or "none"] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose) as rated in the participant's diary. The TNSS was the sum of the 4 nasal symptom sub-scores. TNSS scores ranged from 0 to 16, with a higher score indicating more frequent/severe nasal symptoms. Baseline (BL) measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement was an average from Day 1 to Day 13 (2 week average). Change from BL = Post BL measurement - BL measurement.](streamdown:incomplete-link) | The Full Analysis Set (FAS); all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation (average score of 2 weeks). | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Day 1 to Day 13 (Weeks 1 through 2 average) of double-blind treatment |
Up to 4 weeks (Up to 2 weeks after last dose of study drug)
APaT; all participants who received ≥1 dose of study treatment. One participant randomized to Desloratadine was not treated due to withdrawn consent.
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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 | Desloratadine | After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative wound infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| 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 |
|---|---|
| C121345 | desloratadine |
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| Drug |
Placebo tablets |
|
| Up to 2 weeks |
| Baseline, Day 1 to 7 (Week 1 average), Day 8 to 13 (Week 2 average) of double-blind treatment |
| Change From Baseline to Week 1 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) | Nasal symptoms sub-scores rated in the participant's diary included sneezing (daily frequency of attacks scored from 0 [<1 time or "none"] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or "none"] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores ranged from 0 to 4, with a higher score indicating more frequent/severe nasal symptoms. BL measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement for Week 1 was an average of scores from Day 1 to Day 7. Change from BL = Post BL measurement - BL measurement.](streamdown:incomplete-link) | Baseline, Day 1 to 7 (Week 1 average) of double-blind treatment |
| Change From Baseline to Week 2 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) | Nasal symptoms sub-scores rated in the participant's diary included sneezing (daily frequency of attacks scored from 0 [<1 time or "none"] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or "none"] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores ranged from 0 to 4, with a higher score indicating more frequent/severe nasal symptoms. BL measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement for Week 2 was an average of scores from Day 8 to Day 13. Change from BL = Post BL measurement - BL measurement.](streamdown:incomplete-link) | Baseline, Day 8 to 13 (Week 2 average) of double-blind treatment |
| Change From Baseline in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) During 2 Weeks of Therapy | Nasal symptoms sub-scores rated in the participant's diary included sneezing (daily frequency of attacks scored from 0 [<1 time or "none"] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or "none"] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores ranged from 0 to 4, with a higher score indicating more frequent/severe nasal symptoms. BL measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement for 2 week Average was an average of scores from Day 1 to Day 13. Change from BL = Post BL measurement - BL measurement.](streamdown:incomplete-link) | Baseline, Day 1 to Day 13 (Weeks 1 through 2 average) |
| Change From Baseline to Week 1 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes) | Eye symptoms rated in the participant's diary included eye pruritis (eye itching scored from 0 [none] to 4 [severe eye itching, requiring frequent rubbing of eye]) and watering eyes (scored from 0 [none] to 4 [severe eye watering requiring frequent wiping of eyes]). Eye symptom scores ranged from 0 to 4, with a higher score indicating greater severity of symptom. The change from baseline in eye pruritis, eye watering, and the worse one of either eye symptom were reported. Baseline measurement was an average of scores for 3 days prior to treatment. Post-baseline measurement for Week 1 was an average of scores from Day 1 to Day 7. Change from BL = Post BL measurement - BL measurement. | Baseline, Day 1 to 7 (Week 1 average) of double-blind treatment |
| Change From Baseline to Week 2 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes) | Eye symptoms rated in the participant's diary included eye pruritis (eye itching scored from 0 [none] to 4 [severe eye itching, requiring frequent rubbing of eye]) and watering eyes (scored from 0 [none] to 4 [severe eye watering requiring frequent wiping of eyes]). Eye symptom scores ranged from 0 to 4, with a higher score indicating greater severity of symptom. The change from baseline in eye pruritis, eye watering, and the worse one of either eye symptom were reported. Baseline measurement was an average of scores for 3 days prior to treatment. Post-BL measurement for Week 2 was an average of scores from Day 8 to Day 13. Change from BL = Post BL measurement - BL measurement. | Baseline, Day 8 to 13 (Week 2) of double-blind treatment |
| Change From Baseline in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes) During 2 Weeks of Therapy | Eye symptoms rated in the participant's diary included eye pruritis (eye itching scored from 0 [none] to 4 [severe eye itching, requiring frequent rubbing of eye]) and watering eyes (scored from 0 [none] to 4 [severe eye watering requiring frequent wiping of eyes]). Eye symptom scores ranged from 0 to 4, with a higher score indicating greater severity of symptom. The change from baseline in eye pruritis, eye watering, and the worse one of either eye symptom were reported. BL measurement was an average of scores for 3 days prior to treatment. Post-BL measurement for 2 week Average was an average of scores from Day 1 to Day 13. Change from BL = Post BL measurement - BL measurement. | Baseline, Day 1 to Day 13 (Weeks 1 through 2 average) |
| Change From Baseline in Interference With Daily Activities Score at Week 1, Week 2, and During 2 Weeks of Therapy | Interference of allergic rhinitis symptoms with overall daily activities (such as work, study, housekeeping, sleep, or outing) was rated by the participant according to the following scale: 0=none, 1= symptoms cause few troubles, 2=symptoms cause intermediate problems between 1 and 3, 3=nasal symptoms cause painful and complicating daily life, or 4 = symptoms make daily activities impossible. Interference with daily activities scores ranged from 0 to 4 maximum, with a higher score indicating greater interference with daily activities. Baseline measurement was an average of scores for 3 days prior to treatment. Post-baseline measurement for Week 1 was an average of scores from Day 1 to Day 7. Post-BL measurement for Week 2 was an average of scores from Day 8 to Day 13. Post-BL measurement for 2 week Average was an average of scores from Day 1 to Day 13. Change from BL = Post BL measurement - BL measurement. | Baseline, Day 1 to 7 (Week 1 average), Day 8 to 13 (Week 2 average), Day 1 to Day 13 (Weeks 1 through 2 average) of double-blind treatment |
| Percentage of Participants With Impression Assessments of "Better" or "Much Better" as Assessed by the Investigator at Week 2 | The investigator assessed the participant's symptoms of allergic rhinitis and nasal findings at the end of the study (2 week visit or discontinuation visit) compared with those at the start of the study period (based on their recollection/memory of the participant's symptoms, no formal baseline assessment) and evaluated their impression of study drug on effect according to 6 grades: Much better, Better, Slightly better, Unchanged, Worse, or Unevaluable. The evaluation result and reason for judgment (if needed) was recorded in the participant's case report form. The investigator's impression was evaluated based on the symptoms for allergic rhinitis, nasal findings and participant's own impression at Week 2. The percentage of participants with assessments of "Better" and "Much better" graded by the investigator (Investigator's Impression Rate) was reported and analyzed using Odds Ratio analysis. | From Baseline to Week 2 |
| Percentage of Participants With Impression Assessments of "Better" or "Much Better" as Assessed Participants at Week 2 | The participant evaluated their symptoms of allergic rhinitis at the end of the study (2 week visit or discontinuation visit) compared with those at the start of the study period (based on their recollection/memory of their symptoms, no formal baseline assessment) and recorded in their Subject Allergy Diary their impression of study drug on effect according to 6 grades: Much better, Better, Slightly better, Unchanged, Worse, or Unevaluable. The percentage of participants with assessments of "Better" and "Much better" graded by the participant (Participant's Impression Rate) was reported and analyzed using Odds Ratio analysis. | From Baseline to Week 2 |
| Protocol Violation |
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| Withdrawal by Subject |
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After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Primary | Number of Participants Who Experience at Least One Adverse Event (AE) | An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE. | All Participants as Treated (APaT); all participants who received ≥1 dose of study treatment. | Posted | Number | participants | Up to 4 weeks (Up to 2 weeks after last dose of study drug) |
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| Primary | Number of Participants Who Discontinue Study Drug Due to an AE | An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE. | APaT; all participants who received ≥1 dose of study treatment. | Posted | Number | participants | Up to 2 weeks |
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| Secondary | Change From Baseline in TNSS for Week 1 and Week 2 of Double-blind Treatment | The TNSS was used to evaluate participant nasal symptoms of: sneezing (daily frequency of attacks scored from 0 [<1 time or "none"] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or "none"] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose) as rated in the participant's diary. The TNSS was the sum of the 4 nasal symptom sub-scores. TNSS scores ranged from 0 to 16, with a higher score indicating more frequent/severe nasal symptoms. Baseline (BL) measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement for Week 1 was an average from Day 1 to Day 7 and post-BL measurement for Week 2 was an average from Day 8 to Day 13. Change from BL = Post BL measurement - BL measurement.](streamdown:incomplete-link) | The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Day 1 to 7 (Week 1 average), Day 8 to 13 (Week 2 average) of double-blind treatment |
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| Secondary | Change From Baseline to Week 1 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) | Nasal symptoms sub-scores rated in the participant's diary included sneezing (daily frequency of attacks scored from 0 [<1 time or "none"] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or "none"] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores ranged from 0 to 4, with a higher score indicating more frequent/severe nasal symptoms. BL measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement for Week 1 was an average of scores from Day 1 to Day 7. Change from BL = Post BL measurement - BL measurement.](streamdown:incomplete-link) | The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Day 1 to 7 (Week 1 average) of double-blind treatment |
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| Secondary | Change From Baseline to Week 2 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) | Nasal symptoms sub-scores rated in the participant's diary included sneezing (daily frequency of attacks scored from 0 [<1 time or "none"] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or "none"] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores ranged from 0 to 4, with a higher score indicating more frequent/severe nasal symptoms. BL measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement for Week 2 was an average of scores from Day 8 to Day 13. Change from BL = Post BL measurement - BL measurement.](streamdown:incomplete-link) | The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Day 8 to 13 (Week 2 average) of double-blind treatment |
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| Secondary | Change From Baseline in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) During 2 Weeks of Therapy | Nasal symptoms sub-scores rated in the participant's diary included sneezing (daily frequency of attacks scored from 0 [<1 time or "none"] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or "none"] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores ranged from 0 to 4, with a higher score indicating more frequent/severe nasal symptoms. BL measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement for 2 week Average was an average of scores from Day 1 to Day 13. Change from BL = Post BL measurement - BL measurement.](streamdown:incomplete-link) | The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Day 1 to Day 13 (Weeks 1 through 2 average) |
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| Secondary | Change From Baseline to Week 1 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes) | Eye symptoms rated in the participant's diary included eye pruritis (eye itching scored from 0 [none] to 4 [severe eye itching, requiring frequent rubbing of eye]) and watering eyes (scored from 0 [none] to 4 [severe eye watering requiring frequent wiping of eyes]). Eye symptom scores ranged from 0 to 4, with a higher score indicating greater severity of symptom. The change from baseline in eye pruritis, eye watering, and the worse one of either eye symptom were reported. Baseline measurement was an average of scores for 3 days prior to treatment. Post-baseline measurement for Week 1 was an average of scores from Day 1 to Day 7. Change from BL = Post BL measurement - BL measurement. | The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Day 1 to 7 (Week 1 average) of double-blind treatment |
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| Secondary | Change From Baseline to Week 2 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes) | Eye symptoms rated in the participant's diary included eye pruritis (eye itching scored from 0 [none] to 4 [severe eye itching, requiring frequent rubbing of eye]) and watering eyes (scored from 0 [none] to 4 [severe eye watering requiring frequent wiping of eyes]). Eye symptom scores ranged from 0 to 4, with a higher score indicating greater severity of symptom. The change from baseline in eye pruritis, eye watering, and the worse one of either eye symptom were reported. Baseline measurement was an average of scores for 3 days prior to treatment. Post-BL measurement for Week 2 was an average of scores from Day 8 to Day 13. Change from BL = Post BL measurement - BL measurement. | The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Day 8 to 13 (Week 2) of double-blind treatment |
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| Secondary | Change From Baseline in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes) During 2 Weeks of Therapy | Eye symptoms rated in the participant's diary included eye pruritis (eye itching scored from 0 [none] to 4 [severe eye itching, requiring frequent rubbing of eye]) and watering eyes (scored from 0 [none] to 4 [severe eye watering requiring frequent wiping of eyes]). Eye symptom scores ranged from 0 to 4, with a higher score indicating greater severity of symptom. The change from baseline in eye pruritis, eye watering, and the worse one of either eye symptom were reported. BL measurement was an average of scores for 3 days prior to treatment. Post-BL measurement for 2 week Average was an average of scores from Day 1 to Day 13. Change from BL = Post BL measurement - BL measurement. | The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Day 1 to Day 13 (Weeks 1 through 2 average) |
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| Secondary | Change From Baseline in Interference With Daily Activities Score at Week 1, Week 2, and During 2 Weeks of Therapy | Interference of allergic rhinitis symptoms with overall daily activities (such as work, study, housekeeping, sleep, or outing) was rated by the participant according to the following scale: 0=none, 1= symptoms cause few troubles, 2=symptoms cause intermediate problems between 1 and 3, 3=nasal symptoms cause painful and complicating daily life, or 4 = symptoms make daily activities impossible. Interference with daily activities scores ranged from 0 to 4 maximum, with a higher score indicating greater interference with daily activities. Baseline measurement was an average of scores for 3 days prior to treatment. Post-baseline measurement for Week 1 was an average of scores from Day 1 to Day 7. Post-BL measurement for Week 2 was an average of scores from Day 8 to Day 13. Post-BL measurement for 2 week Average was an average of scores from Day 1 to Day 13. Change from BL = Post BL measurement - BL measurement. | The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Day 1 to 7 (Week 1 average), Day 8 to 13 (Week 2 average), Day 1 to Day 13 (Weeks 1 through 2 average) of double-blind treatment |
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| Secondary | Percentage of Participants With Impression Assessments of "Better" or "Much Better" as Assessed by the Investigator at Week 2 | The investigator assessed the participant's symptoms of allergic rhinitis and nasal findings at the end of the study (2 week visit or discontinuation visit) compared with those at the start of the study period (based on their recollection/memory of the participant's symptoms, no formal baseline assessment) and evaluated their impression of study drug on effect according to 6 grades: Much better, Better, Slightly better, Unchanged, Worse, or Unevaluable. The evaluation result and reason for judgment (if needed) was recorded in the participant's case report form. The investigator's impression was evaluated based on the symptoms for allergic rhinitis, nasal findings and participant's own impression at Week 2. The percentage of participants with assessments of "Better" and "Much better" graded by the investigator (Investigator's Impression Rate) was reported and analyzed using Odds Ratio analysis. | Participants in the FAS (all randomized participants who took ≥1 dose of study treatment) with available impression data. | Posted | Number | percentage of participants | From Baseline to Week 2 |
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| Secondary | Percentage of Participants With Impression Assessments of "Better" or "Much Better" as Assessed Participants at Week 2 | The participant evaluated their symptoms of allergic rhinitis at the end of the study (2 week visit or discontinuation visit) compared with those at the start of the study period (based on their recollection/memory of their symptoms, no formal baseline assessment) and recorded in their Subject Allergy Diary their impression of study drug on effect according to 6 grades: Much better, Better, Slightly better, Unchanged, Worse, or Unevaluable. The percentage of participants with assessments of "Better" and "Much better" graded by the participant (Participant's Impression Rate) was reported and analyzed using Odds Ratio analysis. | Participants in the FAS (all randomized participants who took ≥1 dose of study treatment) with available impression data. | Posted | Number | percentage of participants | From Baseline to Week 2 |
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| 1 |
| 223 |
| 0 |
| 223 |
| EG001 | Placebo | After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period. | 0 | 225 | 0 | 225 |
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Change from BL in TNSS at Week 2: Desloratadine vs. Placebo The LS mean change from BL to Week 2 post BL in TNSS was estimated using a cLDA model, where both BL and post- BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value. | cLDA model | <0.001 | Difference in LS Means | -0.84 | 2-Sided | 95 | -1.23 | -0.46 | Superiority or Other (legacy) |
| Nasal Congestion |
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| Nasal Itching |
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| Change from BL to Week 1 in Rhinorrhea: Desloratadine vs. Placebo The LS mean change from BL to Week 1 post BL in Rhinorrhea was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value. | cLDA model | <0.001 | Difference in LS Means | -0.21 | 2-Sided | 95 | -0.32 | -0.10 | Superiority or Other (legacy) |
| Change from BL to Week 1 in Nasal Congestion: Desloratadine vs. Placebo The LS mean change from BL to Week 1 post BL in Nasal Congestion was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value. | cLDA model | 0.008 | Difference in LS Means | -0.09 | 2-Sided | 95 | -0.16 | -0.02 | Superiority or Other (legacy) |
| Change from BL to Week 1 in Nasal Itching: Desloratadine vs. Placebo The LS mean change from BL to Week 1 post BL in Nasal Itching was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value. | cLDA model | <0.001 | Difference in LS Means | -0.27 | 2-Sided | 95 | -0.38 | -0.15 | Superiority or Other (legacy) |
| Nasal Congestion |
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| Nasal Itching |
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| Change from BL to Week 2 in Rhinorrhea: Desloratadine vs. Placebo The LS mean change from BL to Week 2 post BL in Rhinorrhea was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value. | cLDA model | <0.001 | Difference in LS Means | -0.25 | 2-Sided | 95 | -0.37 | -0.12 | Superiority or Other (legacy) |
| Change from BL to Week 2 in Nasal Congestion: Desloratadine vs. Placebo The LS mean change from BL to Week 2 post BL in Nasal Congestion was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value. | cLDA model | 0.037 | Difference in LS Means | -0.09 | 2-Sided | 95 | -0.18 | -0.01 | Superiority or Other (legacy) |
| Change from BL to Week 2 in Nasal Itching: Desloratadine vs. Placebo The LS mean change from BL to Week 2 post BL in Nasal Itching was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value. | cLDA model | <0.001 | Difference in LS Means | -0.26 | 2-Sided | 95 | -0.40 | -0.12 | Superiority or Other (legacy) |
| Nasal Congestion |
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| Nasal Itching |
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| Change from BL in Rhinorrhea During 2 Weeks: Desloratadine vs. Placebo The LS mean change from BL to post BL (average score of 2 weeks) in Rhinorrhea was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value. | cLDA model | <0.001 | Difference in LS Means | -0.23 | 2-Sided | 95 | -0.33 | -0.12 | Superiority or Other (legacy) |
| Change from BL in Nasal Congestion During 2 Weeks: Desloratadine vs. Placebo The LS mean change from BL to post BL (average score of 2 weeks) in Nasal Congestion was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value. | cLDA model | 0.009 | Difference in LS Means | -0.09 | 2-Sided | 95 | -0.16 | -0.02 | Superiority or Other (legacy) |
| Change from BL in Nasal Itching During 2 Weeks: Desloratadine vs. Placebo The LS mean change from BL to post BL (average score of 2 weeks) in Nasal Itching was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value. cLDA model | cLDA model | <0.001 | Difference in LS Means | -0.26 | 2-Sided | 95 | -0.38 | -0.15 | Superiority or Other (legacy) |
| Worse of Pruritus or Watering Eyes |
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| Change from BL to Week 1 in Watering Eyes: Desloratadine vs. Placebo The LS mean change from BL to Week 1 post BL in Watering Eyes was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value. | cLDA model | <0.001 | Difference in LS Means | -0.16 | 2-Sided | 95 | -0.24 | -0.08 | Superiority or Other (legacy) |
| Change from BL to Week 1 in Worse of Pruritus or Watering Eyes: Desloratadine vs. Placebo The LS mean change from BL to Week 1 post BL in the worse symptom of Pruritus or Watering Eyes estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value. | cLDA model | <0.001 | Difference in LS Means | -0.25 | 2-Sided | 95 | -0.35 | -0.15 | Superiority or Other (legacy) |
| Worse of Pruritus or Watering Eyes |
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| Change from BL to Week 2 in Watering Eyes: Desloratadine vs. Placebo The LS mean change from BL to Week 2 post BL in Watering Eyes was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value. | cLDA model | 0.010 | Difference in LS Means | -0.13 | 2-Sided | 95 | -0.24 | -0.03 | Superiority or Other (legacy) |
| Change from BL to Week 2 in Worse of Pruritus or Watering Eyes: Desloratadine vs. Placebo The LS mean change from BL to Week 2 post BL in the worse symptom of Pruritus or Watering Eyes estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value. | cLDA model | <0.001 | Difference in LS Means | -0.24 | 2-Sided | 95 | -0.37 | -0.12 | Superiority or Other (legacy) |
| Worse of Pruritus or Watering Eyes |
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| Change from BL in Watering Eyes During 2 Weeks: Desloratadine vs. Placebo The LS mean change from BL to post BL (average score of 2 weeks) in Watering Eyes was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value. | cLDA model | <0.001 | Difference in LS Means | -0.15 | 2-Sided | 95 | -0.23 | -0.07 | Superiority or Other (legacy) |
| The LS mean change from BL to post BL (average score of 2 weeks) in the worse of Pruritus or Watering Eyes was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1-Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value | cLDA model | <0.001 | Difference in LS Means | -0.25 | 2-Sided | 95 | -0.35 | -0.15 | Superiority or Other (legacy) |
| 2 Week Average |
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| Change from BL to Week 2 in Interference with Daily Activities: Desloratadine vs. Placebo The LS mean change from BL to Week 2 post BL in Interference with Daily Activities was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value. | cLDA model | <0.001 | Difference in LS Means | -0.19 | 2-Sided | 95 | -0.30 | -0.09 | Superiority or Other (legacy) |
| Change from BL in Interference with Daily Activities During 2 Wks: Desloratadine vs. Placebo The LS mean change from BL to post BL (average score of 2 weeks) in Interference with Daily Activities estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1-Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo evaluated with the 95% confidence interval and P-value. | cLDA model | <0.001 | Difference in LS Means | -0.17 | 2-Sided | 95 | -0.26 | -0.08 | Superiority or Other (legacy) |
| Better + Much better Total |
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| Less than better Total |
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| Better + Much better Total |
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| Less than better Total |
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