Trial Outcomes & Findings for Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Eczema/Dermatitis and Dermal Pruritus (MK-4117-202) (NCT NCT01916980)
NCT ID: NCT01916980
Last Updated: 2024-06-18
Results Overview
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 sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher sum score indicating greater severity. The change from Baseline in the sum of the daytime and nighttime pruritus/itch scores at Week 2 clinic visit was calculated.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
94 participants
Primary outcome timeframe
Baseline Visit and Week 2 Visit
Results posted on
2024-06-18
Participant Flow
Participant milestones
| Measure |
Desloratadine: Eczema/Dermatitis
Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
|
Desloratadine: Dermal Pruritus
Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
29
|
|
Overall Study
COMPLETED
|
58
|
25
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
Reasons for withdrawal
| Measure |
Desloratadine: Eczema/Dermatitis
Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
|
Desloratadine: Dermal Pruritus
Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
2
|
|
Overall Study
Lack of Efficacy
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Eczema/Dermatitis and Dermal Pruritus (MK-4117-202)
Baseline characteristics by cohort
| Measure |
Desloratadine: Eczema/Dermatitis
n=65 Participants
Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
|
Desloratadine: Dermal Pruritus
n=29 Participants
Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.0 Years
STANDARD_DEVIATION 15.2 • n=93 Participants
|
44.1 Years
STANDARD_DEVIATION 21.5 • n=4 Participants
|
36.4 Years
STANDARD_DEVIATION 18.0 • n=27 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
|
Investigator-assessed Sum of Daytime and Nighttime Pruritus/Itch Scores at Baseline
|
4.75 Score on a Scale
STANDARD_DEVIATION 1.10 • n=93 Participants
|
5.10 Score on a Scale
STANDARD_DEVIATION 1.47 • n=4 Participants
|
4.86 Score on a Scale
STANDARD_DEVIATION 1.23 • n=27 Participants
|
|
Participant-assessed Pruritus Visual Analog Scale (VAS) Score at Baseline
|
60.42 Score on a Scale
STANDARD_DEVIATION 18.94 • n=93 Participants
|
60.79 Score on a Scale
STANDARD_DEVIATION 24.45 • n=4 Participants
|
60.53 Score on a Scale
STANDARD_DEVIATION 20.66 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline Visit and Week 2 VisitPopulation: The Full Analysis Set (FAS) population consisted of all participants who received at least one dose of study drug and had a Baseline or at least one post-Baseline observation for Investigator-assessed pruritus/itch score.
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 sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher sum score indicating greater severity. The change from Baseline in the sum of the daytime and nighttime pruritus/itch scores at Week 2 clinic visit was calculated.
Outcome measures
| Measure |
Desloratadine: Eczema/Dermatitis
n=65 Participants
Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
|
Desloratadine: Dermal Pruritus
n=29 Participants
Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
|
|---|---|---|
|
Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Week 2
|
-1.63 Score on a Scale
Interval -2.01 to -1.25
|
-2.17 Score on a Scale
Interval -2.74 to -1.61
|
PRIMARY outcome
Timeframe: Up to 14 weeks (Up to 2 weeks after last dose dose of study drug)Population: The All-Participants-as-Treated (APaT) population consisted of all participants who received at least one 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.
Outcome measures
| Measure |
Desloratadine: Eczema/Dermatitis
n=65 Participants
Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
|
Desloratadine: Dermal Pruritus
n=29 Participants
Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
|
|---|---|---|
|
Percentage of Participants Who Experienced at Least One Adverse Event (AE)
|
53.8 Percentage of Participants
|
48.3 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: The APaT population consisted of all participants who received at least one 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.
Outcome measures
| Measure |
Desloratadine: Eczema/Dermatitis
n=65 Participants
Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
|
Desloratadine: Dermal Pruritus
n=29 Participants
Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
|
|---|---|---|
|
Percentage of Participants Who Discontinued Study Drug Due to an AE
|
6.2 Percentage of Participants
|
6.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline Visit and Day 3 Visit, Week 1 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 VisitPopulation: The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline or at least one post-Baseline observation for Investigator-assessed pruritus/itch score.
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 sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher sum score indicating greater severity. The changes from Baseline in the sum of the daytime and nighttime pruritus/itch scores at the Day 3, Week 1, Week 4, Week 6, Week 8 and Week 12 clinic visits were calculated.
Outcome measures
| Measure |
Desloratadine: Eczema/Dermatitis
n=65 Participants
Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
|
Desloratadine: Dermal Pruritus
n=29 Participants
Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
|
|---|---|---|
|
Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Day 3, Week 1, Week 4, Week 6, Week 8 and Week 12
Change from Baseline at Week 1 (n=65, 29)
|
-1.29 Score on a Scale
Interval -1.66 to -0.92
|
-2.07 Score on a Scale
Interval -2.62 to -1.52
|
|
Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Day 3, Week 1, Week 4, Week 6, Week 8 and Week 12
Change from Baseline at Day 3 (n=65, 29)
|
-0.83 Score on a Scale
Interval -1.18 to -0.49
|
-1.59 Score on a Scale
Interval -2.1 to -1.07
|
|
Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Day 3, Week 1, Week 4, Week 6, Week 8 and Week 12
Change from Baseline at Week 4 (n=63, 28)
|
-1.88 Score on a Scale
Interval -2.29 to -1.47
|
-2.39 Score on a Scale
Interval -3.01 to -1.78
|
|
Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Day 3, Week 1, Week 4, Week 6, Week 8 and Week 12
Change from Baseline at Week 6 (n=62, 26)
|
-2.33 Score on a Scale
Interval -2.72 to -1.94
|
-2.48 Score on a Scale
Interval -3.07 to -1.89
|
|
Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Day 3, Week 1, Week 4, Week 6, Week 8 and Week 12
Change from Baseline at Week 8 (n=61, 25)
|
-2.18 Score on a Scale
Interval -2.59 to -1.76
|
-3.15 Score on a Scale
Interval -3.79 to -2.52
|
|
Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Day 3, Week 1, Week 4, Week 6, Week 8 and Week 12
Change from Baseline at Week 12 (n=58, 25)
|
-2.51 Score on a Scale
Interval -2.89 to -2.14
|
-3.47 Score on a Scale
Interval -4.04 to -2.9
|
SECONDARY outcome
Timeframe: Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 VisitPopulation: The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline or at least one post-Baseline observation for Investigator-assessed Global Improvement.
The global improvement judgment criteria were used to assess overall improvement in pruritus/itch. The Investigator assessed the degree of severity of pruritus/itch based on 5 grades (1=Remarkably improved to 5=Aggravated) at Baseline and subsequent clinic visits. The percentages of participants who were remarkably improved (Grade 1=Pruritus/itch disappeared) or moderately improved (Grade 2=Pruritus/itch was greatly improved) at the Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12 clinic visits were calculated.
Outcome measures
| Measure |
Desloratadine: Eczema/Dermatitis
n=65 Participants
Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
|
Desloratadine: Dermal Pruritus
n=29 Participants
Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
|
|---|---|---|
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Percentage of Participants With Moderate or Remarkable Improvement in the Global Improvement Rate of Pruritus/Itch Assessed by the Investigator at Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12
Week 1
|
29.2 Percentage of Participants
|
51.7 Percentage of Participants
|
|
Percentage of Participants With Moderate or Remarkable Improvement in the Global Improvement Rate of Pruritus/Itch Assessed by the Investigator at Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12
Week 4
|
50.8 Percentage of Participants
|
62.1 Percentage of Participants
|
|
Percentage of Participants With Moderate or Remarkable Improvement in the Global Improvement Rate of Pruritus/Itch Assessed by the Investigator at Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12
Day 3
|
16.9 Percentage of Participants
|
34.5 Percentage of Participants
|
|
Percentage of Participants With Moderate or Remarkable Improvement in the Global Improvement Rate of Pruritus/Itch Assessed by the Investigator at Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12
Week 2
|
33.8 Percentage of Participants
|
51.7 Percentage of Participants
|
|
Percentage of Participants With Moderate or Remarkable Improvement in the Global Improvement Rate of Pruritus/Itch Assessed by the Investigator at Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12
Week 6
|
60.0 Percentage of Participants
|
62.1 Percentage of Participants
|
|
Percentage of Participants With Moderate or Remarkable Improvement in the Global Improvement Rate of Pruritus/Itch Assessed by the Investigator at Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12
Week 8
|
63.1 Percentage of Participants
|
62.1 Percentage of Participants
|
|
Percentage of Participants With Moderate or Remarkable Improvement in the Global Improvement Rate of Pruritus/Itch Assessed by the Investigator at Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12
Week 12
|
69.2 Percentage of Participants
|
62.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 VisitPopulation: The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline or at least one post-Baseline observation for participant-assessed pruritus/itch VAS score.
Participants assessed the degree of their pruritus using a 100-mm visual analog scale (VAS; 0mm=No itch, 100mm=Worst imaginable itch) at Baseline and subsequent clinic visits. Pruritus/itch VAS scores could range from 0 to 100, with a higher score indicating more severe pruritus/itching. The changes from Baseline in the VAS scores for pruritus/itch at the Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12 clinic visits were calculated.
Outcome measures
| Measure |
Desloratadine: Eczema/Dermatitis
n=65 Participants
Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
|
Desloratadine: Dermal Pruritus
n=29 Participants
Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
|
|---|---|---|
|
Change From Baseline in the Pruritus/Itch Visual Analog Scale (VAS) Score Recorded by Participants at Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12
Change from Baseline at Day 3 (n=65, 29)
|
-10.03 Score on a Scale
Interval -15.22 to -4.84
|
-21.90 Score on a Scale
Interval -29.66 to -14.13
|
|
Change From Baseline in the Pruritus/Itch Visual Analog Scale (VAS) Score Recorded by Participants at Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12
Change from Baseline at Week 1 (n=65, 29)
|
-12.17 Score on a Scale
Interval -17.92 to -6.42
|
-24.72 Score on a Scale
Interval -33.33 to -16.12
|
|
Change From Baseline in the Pruritus/Itch Visual Analog Scale (VAS) Score Recorded by Participants at Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12
Change from Baseline at Week 2 (n=63, 29)
|
-18.95 Score on a Scale
Interval -25.18 to -12.72
|
-28.45 Score on a Scale
Interval -37.72 to -19.18
|
|
Change From Baseline in the Pruritus/Itch Visual Analog Scale (VAS) Score Recorded by Participants at Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12
Change from Baseline at Week 4 (n=63, 28)
|
-22.36 Score on a Scale
Interval -29.01 to -15.71
|
-27.74 Score on a Scale
Interval -37.66 to -17.82
|
|
Change From Baseline in the Pruritus/Itch Visual Analog Scale (VAS) Score Recorded by Participants at Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12
Change from Baseline at Week 6 (n=62, 26)
|
-27.26 Score on a Scale
Interval -33.2 to -21.32
|
-30.71 Score on a Scale
Interval -39.7 to -21.72
|
|
Change From Baseline in the Pruritus/Itch Visual Analog Scale (VAS) Score Recorded by Participants at Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12
Change from Baseline at Week 8 (n=61, 25)
|
-29.87 Score on a Scale
Interval -36.55 to -23.2
|
-32.44 Score on a Scale
Interval -42.6 to -22.29
|
|
Change From Baseline in the Pruritus/Itch Visual Analog Scale (VAS) Score Recorded by Participants at Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12
Change from Baseline at Week 12 (n=58, 25)
|
-33.02 Score on a Scale
Interval -39.65 to -26.39
|
-38.74 Score on a Scale
Interval -48.76 to -28.73
|
Adverse Events
Desloratadine: Eczema/Dermatitis
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Desloratadine: Dermal Pruritus
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Desloratadine: Eczema/Dermatitis
n=65 participants at risk
Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
|
Desloratadine: Dermal Pruritus
n=29 participants at risk
Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
1.5%
1/65 • Number of events 1 • Up to 14 weeks (Up to 2 weeks after last dose of study drug)
|
0.00%
0/29 • Up to 14 weeks (Up to 2 weeks after last dose of study drug)
|
Other adverse events
| Measure |
Desloratadine: Eczema/Dermatitis
n=65 participants at risk
Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
|
Desloratadine: Dermal Pruritus
n=29 participants at risk
Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
20.0%
13/65 • Number of events 16 • Up to 14 weeks (Up to 2 weeks after last dose of study drug)
|
13.8%
4/29 • Number of events 4 • Up to 14 weeks (Up to 2 weeks after last dose of study drug)
|
|
Nervous system disorders
Somnolence
|
6.2%
4/65 • Number of events 4 • Up to 14 weeks (Up to 2 weeks after last dose of study drug)
|
0.00%
0/29 • Up to 14 weeks (Up to 2 weeks after last dose of study drug)
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/65 • Up to 14 weeks (Up to 2 weeks after last dose of study drug)
|
6.9%
2/29 • Number of events 2 • Up to 14 weeks (Up to 2 weeks after last dose of study drug)
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER