Urticaria
Conditions
Keywords
Urticaria, Skin Diseases, Vascular, Skin Diseases, Hypersensitivity, Immediate, Hypersensitivity, Immune System Diseases, Cholinergic Antagonists, Cholinergic Agents, Neurotransmitter Agents, Histamine H1 Antagonists, Non-Sedating, Histamine H1 Antagonists, Histamine Antagonists, Histamine Agents
Brief summary
This is a study to evaluate the efficacy and safety of desloratadine (MK-4117) in Japanese participants with chronic urticaria. The primary hypothesis is that the efficacy of desloratadine 10 mg and 5 mg is superior to placebo as based on the change from Baseline in the sum score of pruritus/itch and rash as assessed by the Investigator at Week 2.
Interventions
DRUGDesloratadine
Desloratadine 5 mg tablets, given orally, once daily in the evening for 2 weeks
DRUGPlacebo
Placebo tablets, given orally, once daily in the evening for 2 weeks
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic urticaria \[rash (erythema, wheal) for more than 1 month without any known cause\] * Out-patient
Exclusion criteria
* Stimulation-induced urticaria \[physical urticaria (e.g. cold, solar, and heat urticaria), cholinergic urticaria, contact urticaria)\] * Hypersensitivity to antihistamines or ingredients of a study drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Week 2 | Baseline Visit and Week 2 Visit | The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The score used for pruritus/itch was the higher of the day or night scores (0=Asymptomatic to 4=Severe). The Investigator also assessed the severity of participant rash using the overall rash score (0=No rash to 3=Looks very bad). The sum of the pruritus/itch score (0-4) and rash score (0-3) could range from 0 to 7, with a higher sum score indicating greater severity. The change from Baseline in the sum of the pruritus/itch and overall rash scores at the Week 2 clinic visit was calculated. |
| Number of Participants Who Experienced at Least One Adverse Event (AE) | Up to 4 weeks (Up to 2 weeks after last dose of study drug) | An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. |
| Number of Participants Who Discontinued Study Drug Due to an AE | Up to 2 weeks | An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Moderate or Remarkable Improvement in the Global Improvement Rate of Both Pruritus/Itch and Rash (Erythema and Wheal) Assessed by the Investigator at Day 3, Week 1 and Week 2 | Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit | The global improvement judgment criteria were used to assess overall improvement in pruritus/itch and rash. The Investigator assessed participant global improvement according to 5 grades (Grade 1=Remarkable improvement to Grade 5=Aggravated). The number of participants with moderate or remarkable improvements was calculated. Remarkable improvement (Grade 1) was defined as both pruritus/itch and rash (erythema and wheal) disappeared, or pruritus/itch disappeared and rash (erythema and wheal) was apparently improved. Moderate improvement (Grade 2) was defined as both pruritus/itch and rash (erythema and wheal) were greatly improved. |
| Change From Baseline in the Pruritus/Itch Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 | Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit | Participants assessed the severity of their pruritus/itch during the daytime and nighttime (0=asymptomatic to 4=severe). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher score indicating greater severity. The changes from Baseline in the sum of the daytime and nighttime scores at the Day 3, Week 1 and Week 2 clinic visits were calculated. |
| Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Day 3 and Week 1 | Baseline Visit and Day 3 Visit, Week 1 Visit | The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The score used for pruritus/itch was the higher of the day or night scores (0=Asymptomatic to 4=Severe). The Investigator also assessed the severity of participant rash using the overall rash score (0=No rash to 3=Looks very bad). The sum of the pruritus/itch score (0-4) and rash score (0-3) could range from 0 to 7, with a higher sum score indicating greater severity. The changes from Baseline in the sum of the pruritus/itch and overall rash scores at the Day 3 and Week 1 clinic visits were calculated. |
| Change From Baseline in the Rash Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 | Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit | Participants assessed the severity of their rash (erythema: 0=no symptom to 3=intensive redness, and wheal: 0=no symptom to 3=significant ridge). The sum score for erythema plus wheal could range from 0 to 6, with a higher score indicating greater severity. The changes from Baseline in the sum score for erythema plus wheal at the Day 3, Week 1 and Week 2 clinic visits were calculated. |
| Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score Reported by Participants at Week 1 and Week 2 | Baseline Visit and Week 1 Visit, Week 2 Visit | The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses to questions about the effect of participant skin problems on life ranged from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life. Participants \>=16 years of age completed the DLQI questionnaire about the condition of their skin over the previous week. The changes from Baseline in the DLQI total score at the Week 1 and Week 2 clinic visits were calculated. |
| Change From Baseline in Pruritus/Itch on a Visual Analog Scale (VAS) Reported by Participants at Day 3, Week 1 and Week 2 | Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit | Participants assessed the degree of their pruritus/itching using a 100-mm visual analog scale (VAS) (0 mm=No itch to 100 mm=Worst imaginable itch), with a higher score indicating more severe itching. The changes from Baseline in participant-assessed pruritus/itch at the Day 3, Week 1 and Week 2 clinic visits were calculated. |
| Change From Baseline in the Pruritus/Itch Score Assessed by Investigator at Day 3, Week 1 and Week 2 | Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit | The Investigator assessed the severity of participant pruritus/itch during the daytime and nighttime (0=Asymptomatic to 4=Severe). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher score indicating greater severity. The changes from Baseline in the sum of the daytime and nighttime scores at the Day 3, Week 1 and Week 2 clinic visits were calculated. |
| Change From Baseline in the Rash Score Assessed by Investigator at Day 3, Week 1 and Week 2 | Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit | The Investigator assessed the severity of participant rash (erythema: 0=no symptom to 3=intensive redness, and wheal: 0=no symptom to 3=significant ridge). The sum score for erythema plus wheal could range from 0 to 6, with a higher score indicating greater severity. The changes from Baseline in the sum score for erythema plus wheal at the Day 3, Week 1 and Week 2 clinic visits were calculated. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Desloratadine 5 mg Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks | 80 |
| Desloratadine 10 mg Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks | 79 |
| Placebo Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks | 80 |
| Total | 239 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 2 |
| Overall Study | Lack of Efficacy | 0 | 0 | 6 |
| Overall Study | Physician Decision | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Desloratadine 5 mg | Desloratadine 10 mg | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 38.4 Years STANDARD_DEVIATION 16.3 | 40.6 Years STANDARD_DEVIATION 15.8 | 39.3 Years STANDARD_DEVIATION 15.2 | 39.4 Years STANDARD_DEVIATION 15.7 |
| Sex: Female, Male Female | 59 Participants | 48 Participants | 45 Participants | 152 Participants |
| Sex: Female, Male Male | 21 Participants | 31 Participants | 35 Participants | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 80 | 8 / 79 | 5 / 79 | 0 / 1 |
| serious Total, serious adverse events | 0 / 80 | 0 / 79 | 0 / 79 | 0 / 1 |
Outcome results
Primary
Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Week 2
The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The score used for pruritus/itch was the higher of the day or night scores (0=Asymptomatic to 4=Severe). The Investigator also assessed the severity of participant rash using the overall rash score (0=No rash to 3=Looks very bad). The sum of the pruritus/itch score (0-4) and rash score (0-3) could range from 0 to 7, with a higher sum score indicating greater severity. The change from Baseline in the sum of the pruritus/itch and overall rash scores at the Week 2 clinic visit was calculated.
Time frame: Baseline Visit and Week 2 Visit
Population: The Full Analysis Set (FAS) population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and a Week 2 assessment for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Desloratadine 5 mg | Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Week 2 | -3.19 Score on a Scale |
| Desloratadine 10 mg | Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Week 2 | -3.16 Score on a Scale |
| Placebo | Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Week 2 | -2.02 Score on a Scale |
Comparison: Difference in least squares (LS) means of Desloratadine 5 mg and Placebop-value: <0.00195% CI: [-1.69, -0.65]Constrained Longitudinal Data Analysis
Comparison: Difference in LS means of Desloratadine 10 mg and Placebop-value: <0.00195% CI: [-1.66, -0.61]Constrained Longitudinal Data Analysis
Primary
Number of Participants Who Discontinued Study Drug Due to an AE
An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE.
Time frame: Up to 2 weeks
Population: The Safety Population consisted of all participants who received at least one dose of study drug. One Placebo group participant took the wrong study drug. This participant was analyzed separately.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Desloratadine 5 mg | Number of Participants Who Discontinued Study Drug Due to an AE | 0 Participants |
| Desloratadine 10 mg | Number of Participants Who Discontinued Study Drug Due to an AE | 0 Participants |
| Placebo | Number of Participants Who Discontinued Study Drug Due to an AE | 2 Participants |
| Desloratadine 5 mg→Placebo | Number of Participants Who Discontinued Study Drug Due to an AE | 0 Participants |
Primary
Number of Participants Who Experienced at Least One Adverse Event (AE)
An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE.
Time frame: Up to 4 weeks (Up to 2 weeks after last dose of study drug)
Population: The Safety Population consisted of all participants who received at least one dose of study drug. One Placebo group participant took the wrong study drug. This participant was analyzed separately.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Desloratadine 5 mg | Number of Participants Who Experienced at Least One Adverse Event (AE) | 24 Participants |
| Desloratadine 10 mg | Number of Participants Who Experienced at Least One Adverse Event (AE) | 18 Participants |
| Placebo | Number of Participants Who Experienced at Least One Adverse Event (AE) | 16 Participants |
| Desloratadine 5 mg→Placebo | Number of Participants Who Experienced at Least One Adverse Event (AE) | 0 Participants |
Secondary
Change From Baseline in Pruritus/Itch on a Visual Analog Scale (VAS) Reported by Participants at Day 3, Week 1 and Week 2
Participants assessed the degree of their pruritus/itching using a 100-mm visual analog scale (VAS) (0 mm=No itch to 100 mm=Worst imaginable itch), with a higher score indicating more severe itching. The changes from Baseline in participant-assessed pruritus/itch at the Day 3, Week 1 and Week 2 clinic visits were calculated.
Time frame: Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit
Population: The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Desloratadine 5 mg | Change From Baseline in Pruritus/Itch on a Visual Analog Scale (VAS) Reported by Participants at Day 3, Week 1 and Week 2 | Change from Baseline at Week 1 | -40.82 Score on a Scale |
| Desloratadine 5 mg | Change From Baseline in Pruritus/Itch on a Visual Analog Scale (VAS) Reported by Participants at Day 3, Week 1 and Week 2 | Change from Baseline at Day 3 | -35.94 Score on a Scale |
| Desloratadine 5 mg | Change From Baseline in Pruritus/Itch on a Visual Analog Scale (VAS) Reported by Participants at Day 3, Week 1 and Week 2 | Change from Baseline at Week 2 | -45.86 Score on a Scale |
| Desloratadine 10 mg | Change From Baseline in Pruritus/Itch on a Visual Analog Scale (VAS) Reported by Participants at Day 3, Week 1 and Week 2 | Change from Baseline at Week 1 | -48.82 Score on a Scale |
| Desloratadine 10 mg | Change From Baseline in Pruritus/Itch on a Visual Analog Scale (VAS) Reported by Participants at Day 3, Week 1 and Week 2 | Change from Baseline at Day 3 | -39.60 Score on a Scale |
| Desloratadine 10 mg | Change From Baseline in Pruritus/Itch on a Visual Analog Scale (VAS) Reported by Participants at Day 3, Week 1 and Week 2 | Change from Baseline at Week 2 | -45.01 Score on a Scale |
| Placebo | Change From Baseline in Pruritus/Itch on a Visual Analog Scale (VAS) Reported by Participants at Day 3, Week 1 and Week 2 | Change from Baseline at Day 3 | -5.22 Score on a Scale |
| Placebo | Change From Baseline in Pruritus/Itch on a Visual Analog Scale (VAS) Reported by Participants at Day 3, Week 1 and Week 2 | Change from Baseline at Week 2 | -25.24 Score on a Scale |
| Placebo | Change From Baseline in Pruritus/Itch on a Visual Analog Scale (VAS) Reported by Participants at Day 3, Week 1 and Week 2 | Change from Baseline at Week 1 | -15.88 Score on a Scale |
Secondary
Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score Reported by Participants at Week 1 and Week 2
The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses to questions about the effect of participant skin problems on life ranged from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life. Participants \>=16 years of age completed the DLQI questionnaire about the condition of their skin over the previous week. The changes from Baseline in the DLQI total score at the Week 1 and Week 2 clinic visits were calculated.
Time frame: Baseline Visit and Week 1 Visit, Week 2 Visit
Population: The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for DLQI
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Desloratadine 5 mg | Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score Reported by Participants at Week 1 and Week 2 | Change from Baseline at Week 1 | -3.82 Score on a Scale |
| Desloratadine 5 mg | Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score Reported by Participants at Week 1 and Week 2 | Change from Baseline at Week 2 | -4.10 Score on a Scale |
| Desloratadine 10 mg | Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score Reported by Participants at Week 1 and Week 2 | Change from Baseline at Week 1 | -4.08 Score on a Scale |
| Desloratadine 10 mg | Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score Reported by Participants at Week 1 and Week 2 | Change from Baseline at Week 2 | -4.01 Score on a Scale |
| Placebo | Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score Reported by Participants at Week 1 and Week 2 | Change from Baseline at Week 1 | -1.60 Score on a Scale |
| Placebo | Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score Reported by Participants at Week 1 and Week 2 | Change from Baseline at Week 2 | -2.53 Score on a Scale |
Secondary
Change From Baseline in the Pruritus/Itch Score Assessed by Investigator at Day 3, Week 1 and Week 2
The Investigator assessed the severity of participant pruritus/itch during the daytime and nighttime (0=Asymptomatic to 4=Severe). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher score indicating greater severity. The changes from Baseline in the sum of the daytime and nighttime scores at the Day 3, Week 1 and Week 2 clinic visits were calculated.
Time frame: Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit
Population: The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Desloratadine 5 mg | Change From Baseline in the Pruritus/Itch Score Assessed by Investigator at Day 3, Week 1 and Week 2 | Change from Baseline at Week 1 | -2.98 Score on a Scale |
| Desloratadine 5 mg | Change From Baseline in the Pruritus/Itch Score Assessed by Investigator at Day 3, Week 1 and Week 2 | Change from Baseline at Day 3 | -2.62 Score on a Scale |
| Desloratadine 5 mg | Change From Baseline in the Pruritus/Itch Score Assessed by Investigator at Day 3, Week 1 and Week 2 | Change from Baseline at Week 2 | -3.17 Score on a Scale |
| Desloratadine 10 mg | Change From Baseline in the Pruritus/Itch Score Assessed by Investigator at Day 3, Week 1 and Week 2 | Change from Baseline at Week 1 | -3.13 Score on a Scale |
| Desloratadine 10 mg | Change From Baseline in the Pruritus/Itch Score Assessed by Investigator at Day 3, Week 1 and Week 2 | Change from Baseline at Day 3 | -2.72 Score on a Scale |
| Desloratadine 10 mg | Change From Baseline in the Pruritus/Itch Score Assessed by Investigator at Day 3, Week 1 and Week 2 | Change from Baseline at Week 2 | -3.21 Score on a Scale |
| Placebo | Change From Baseline in the Pruritus/Itch Score Assessed by Investigator at Day 3, Week 1 and Week 2 | Change from Baseline at Day 3 | -0.61 Score on a Scale |
| Placebo | Change From Baseline in the Pruritus/Itch Score Assessed by Investigator at Day 3, Week 1 and Week 2 | Change from Baseline at Week 2 | -1.91 Score on a Scale |
| Placebo | Change From Baseline in the Pruritus/Itch Score Assessed by Investigator at Day 3, Week 1 and Week 2 | Change from Baseline at Week 1 | -1.38 Score on a Scale |
Secondary
Change From Baseline in the Pruritus/Itch Score Reported in Participant Diaries at Day 3, Week 1 and Week 2
Participants assessed the severity of their pruritus/itch during the daytime and nighttime (0=asymptomatic to 4=severe). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher score indicating greater severity. The changes from Baseline in the sum of the daytime and nighttime scores at the Day 3, Week 1 and Week 2 clinic visits were calculated.
Time frame: Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit
Population: The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Desloratadine 5 mg | Change From Baseline in the Pruritus/Itch Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 | Change from Baseline at Week 1 | -2.53 Score on a Scale |
| Desloratadine 5 mg | Change From Baseline in the Pruritus/Itch Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 | Change from Baseline at Day 3 | -2.37 Score on a Scale |
| Desloratadine 5 mg | Change From Baseline in the Pruritus/Itch Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 | Change from Baseline at Week 2 | -2.85 Score on a Scale |
| Desloratadine 10 mg | Change From Baseline in the Pruritus/Itch Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 | Change from Baseline at Week 1 | -2.85 Score on a Scale |
| Desloratadine 10 mg | Change From Baseline in the Pruritus/Itch Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 | Change from Baseline at Day 3 | -2.73 Score on a Scale |
| Desloratadine 10 mg | Change From Baseline in the Pruritus/Itch Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 | Change from Baseline at Week 2 | -2.97 Score on a Scale |
| Placebo | Change From Baseline in the Pruritus/Itch Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 | Change from Baseline at Day 3 | -0.50 Score on a Scale |
| Placebo | Change From Baseline in the Pruritus/Itch Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 | Change from Baseline at Week 2 | -1.75 Score on a Scale |
| Placebo | Change From Baseline in the Pruritus/Itch Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 | Change from Baseline at Week 1 | -1.27 Score on a Scale |
Secondary
Change From Baseline in the Rash Score Assessed by Investigator at Day 3, Week 1 and Week 2
The Investigator assessed the severity of participant rash (erythema: 0=no symptom to 3=intensive redness, and wheal: 0=no symptom to 3=significant ridge). The sum score for erythema plus wheal could range from 0 to 6, with a higher score indicating greater severity. The changes from Baseline in the sum score for erythema plus wheal at the Day 3, Week 1 and Week 2 clinic visits were calculated.
Time frame: Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit
Population: The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Desloratadine 5 mg | Change From Baseline in the Rash Score Assessed by Investigator at Day 3, Week 1 and Week 2 | Change from Baseline at Week 1 | -2.65 Score on a Scale |
| Desloratadine 5 mg | Change From Baseline in the Rash Score Assessed by Investigator at Day 3, Week 1 and Week 2 | Change from Baseline at Day 3 | -2.31 Score on a Scale |
| Desloratadine 5 mg | Change From Baseline in the Rash Score Assessed by Investigator at Day 3, Week 1 and Week 2 | Change from Baseline at Week 2 | -2.94 Score on a Scale |
| Desloratadine 10 mg | Change From Baseline in the Rash Score Assessed by Investigator at Day 3, Week 1 and Week 2 | Change from Baseline at Week 1 | -2.98 Score on a Scale |
| Desloratadine 10 mg | Change From Baseline in the Rash Score Assessed by Investigator at Day 3, Week 1 and Week 2 | Change from Baseline at Day 3 | -2.61 Score on a Scale |
| Desloratadine 10 mg | Change From Baseline in the Rash Score Assessed by Investigator at Day 3, Week 1 and Week 2 | Change from Baseline at Week 2 | -2.91 Score on a Scale |
| Placebo | Change From Baseline in the Rash Score Assessed by Investigator at Day 3, Week 1 and Week 2 | Change from Baseline at Day 3 | -0.99 Score on a Scale |
| Placebo | Change From Baseline in the Rash Score Assessed by Investigator at Day 3, Week 1 and Week 2 | Change from Baseline at Week 2 | -1.98 Score on a Scale |
| Placebo | Change From Baseline in the Rash Score Assessed by Investigator at Day 3, Week 1 and Week 2 | Change from Baseline at Week 1 | -1.44 Score on a Scale |
Secondary
Change From Baseline in the Rash Score Reported in Participant Diaries at Day 3, Week 1 and Week 2
Participants assessed the severity of their rash (erythema: 0=no symptom to 3=intensive redness, and wheal: 0=no symptom to 3=significant ridge). The sum score for erythema plus wheal could range from 0 to 6, with a higher score indicating greater severity. The changes from Baseline in the sum score for erythema plus wheal at the Day 3, Week 1 and Week 2 clinic visits were calculated.
Time frame: Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit
Population: The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Desloratadine 5 mg | Change From Baseline in the Rash Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 | Change from Baseline at Week 1 | -2.15 Score on a Scale |
| Desloratadine 5 mg | Change From Baseline in the Rash Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 | Change from Baseline at Day 3 | -2.21 Score on a Scale |
| Desloratadine 5 mg | Change From Baseline in the Rash Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 | Change from Baseline at Week 2 | -2.51 Score on a Scale |
| Desloratadine 10 mg | Change From Baseline in the Rash Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 | Change from Baseline at Week 1 | -2.43 Score on a Scale |
| Desloratadine 10 mg | Change From Baseline in the Rash Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 | Change from Baseline at Day 3 | -2.31 Score on a Scale |
| Desloratadine 10 mg | Change From Baseline in the Rash Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 | Change from Baseline at Week 2 | -2.45 Score on a Scale |
| Placebo | Change From Baseline in the Rash Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 | Change from Baseline at Day 3 | -0.77 Score on a Scale |
| Placebo | Change From Baseline in the Rash Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 | Change from Baseline at Week 2 | -1.70 Score on a Scale |
| Placebo | Change From Baseline in the Rash Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 | Change from Baseline at Week 1 | -1.17 Score on a Scale |
Secondary
Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Day 3 and Week 1
The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The score used for pruritus/itch was the higher of the day or night scores (0=Asymptomatic to 4=Severe). The Investigator also assessed the severity of participant rash using the overall rash score (0=No rash to 3=Looks very bad). The sum of the pruritus/itch score (0-4) and rash score (0-3) could range from 0 to 7, with a higher sum score indicating greater severity. The changes from Baseline in the sum of the pruritus/itch and overall rash scores at the Day 3 and Week 1 clinic visits were calculated.
Time frame: Baseline Visit and Day 3 Visit, Week 1 Visit
Population: The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Desloratadine 5 mg | Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Day 3 and Week 1 | Change from Baseline at Day 3 | -2.57 Score on a Scale |
| Desloratadine 5 mg | Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Day 3 and Week 1 | Change from Baseline at Week 1 | -3.01 Score on a Scale |
| Desloratadine 10 mg | Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Day 3 and Week 1 | Change from Baseline at Day 3 | -2.75 Score on a Scale |
| Desloratadine 10 mg | Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Day 3 and Week 1 | Change from Baseline at Week 1 | -3.16 Score on a Scale |
| Placebo | Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Day 3 and Week 1 | Change from Baseline at Day 3 | -0.80 Score on a Scale |
| Placebo | Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Day 3 and Week 1 | Change from Baseline at Week 1 | -1.39 Score on a Scale |
Secondary
Number of Participants With a Moderate or Remarkable Improvement in the Global Improvement Rate of Both Pruritus/Itch and Rash (Erythema and Wheal) Assessed by the Investigator at Day 3, Week 1 and Week 2
The global improvement judgment criteria were used to assess overall improvement in pruritus/itch and rash. The Investigator assessed participant global improvement according to 5 grades (Grade 1=Remarkable improvement to Grade 5=Aggravated). The number of participants with moderate or remarkable improvements was calculated. Remarkable improvement (Grade 1) was defined as both pruritus/itch and rash (erythema and wheal) disappeared, or pruritus/itch disappeared and rash (erythema and wheal) was apparently improved. Moderate improvement (Grade 2) was defined as both pruritus/itch and rash (erythema and wheal) were greatly improved.
Time frame: Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit
Population: The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Desloratadine 5 mg | Number of Participants With a Moderate or Remarkable Improvement in the Global Improvement Rate of Both Pruritus/Itch and Rash (Erythema and Wheal) Assessed by the Investigator at Day 3, Week 1 and Week 2 | Week 1 | 54 Participants |
| Desloratadine 5 mg | Number of Participants With a Moderate or Remarkable Improvement in the Global Improvement Rate of Both Pruritus/Itch and Rash (Erythema and Wheal) Assessed by the Investigator at Day 3, Week 1 and Week 2 | Day 3 | 54 Participants |
| Desloratadine 5 mg | Number of Participants With a Moderate or Remarkable Improvement in the Global Improvement Rate of Both Pruritus/Itch and Rash (Erythema and Wheal) Assessed by the Investigator at Day 3, Week 1 and Week 2 | Week 2 | 59 Participants |
| Desloratadine 10 mg | Number of Participants With a Moderate or Remarkable Improvement in the Global Improvement Rate of Both Pruritus/Itch and Rash (Erythema and Wheal) Assessed by the Investigator at Day 3, Week 1 and Week 2 | Week 1 | 58 Participants |
| Desloratadine 10 mg | Number of Participants With a Moderate or Remarkable Improvement in the Global Improvement Rate of Both Pruritus/Itch and Rash (Erythema and Wheal) Assessed by the Investigator at Day 3, Week 1 and Week 2 | Day 3 | 55 Participants |
| Desloratadine 10 mg | Number of Participants With a Moderate or Remarkable Improvement in the Global Improvement Rate of Both Pruritus/Itch and Rash (Erythema and Wheal) Assessed by the Investigator at Day 3, Week 1 and Week 2 | Week 2 | 53 Participants |
| Placebo | Number of Participants With a Moderate or Remarkable Improvement in the Global Improvement Rate of Both Pruritus/Itch and Rash (Erythema and Wheal) Assessed by the Investigator at Day 3, Week 1 and Week 2 | Day 3 | 15 Participants |
| Placebo | Number of Participants With a Moderate or Remarkable Improvement in the Global Improvement Rate of Both Pruritus/Itch and Rash (Erythema and Wheal) Assessed by the Investigator at Day 3, Week 1 and Week 2 | Week 2 | 38 Participants |
| Placebo | Number of Participants With a Moderate or Remarkable Improvement in the Global Improvement Rate of Both Pruritus/Itch and Rash (Erythema and Wheal) Assessed by the Investigator at Day 3, Week 1 and Week 2 | Week 1 | 32 Participants |