Back to resultsEfficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Eczema/Dermatitis and Dermal Pruritus (MK-4117-202)
Primary Purpose
Eczema, Dermatitis, Dermal Pruritus
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Desloratadine 5 mg
Sponsored by
About this trial
This is an interventional treatment trial for Eczema focused on measuring Dermatitis, Dermatitis, Atopic, Skin Diseases, Skin Diseases, Genetic, Genetic Diseases, Inborn, Skin Diseases, Eczematous, Hypersensitivity, Immediate, Hypersensitivity, Immune System Diseases
Eligibility Criteria
Inclusion Criteria:
- Eczema/dermatitis (acute eczema, chronic eczema, contact dermatitis, atopic dermatitis, nummular eczema, seborrheic dermatitis, asteatotic eczema, neurodermatitis, etc. among eczema/dermatitis for which the observation of pruritus is appropriate)
- Dermal pruritus (generalized dermal pruritus, localized dermal pruritus)
Exclusion Criteria:
- Hypersensitivity to antihistamines or ingredients of a study drug
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Desloratadine: Eczema/Dermatitis
Desloratadine: Dermal Puritus
Arm Description
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 antipruritic efficacy and there is no safety concern.
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.
Outcomes
Primary Outcome Measures
Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the 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 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.
Percentage 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.
Percentage 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.
Secondary Outcome Measures
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
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.
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
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.
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01916980
Brief Title
Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Eczema/Dermatitis and Dermal Pruritus (MK-4117-202)
Official Title
A Phase III, Multicenter, Open-Label Long-Term Trial to Study the Efficacy and Safety of MK-4117 in Japanese Subjects With Eczema/Dermatitis and Dermal Pruritus.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 27, 2013 (Actual)
Primary Completion Date
March 8, 2014 (Actual)
Study Completion Date
March 22, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an efficacy and safety study of up to 12 weeks of desloratadine in Japanese participants with eczema/dermatitis and dermal pruritus. The primary hypothesis of this study is that the sum of the daytime and nighttime pruritus/itch scores for both the eczema/dermatitis group and the dermal pruritus group will be significantly improved at Week 2 compared to Baseline.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eczema, Dermatitis, Dermal Pruritus
Keywords
Dermatitis, Dermatitis, Atopic, Skin Diseases, Skin Diseases, Genetic, Genetic Diseases, Inborn, Skin Diseases, Eczematous, Hypersensitivity, Immediate, Hypersensitivity, Immune System Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Desloratadine: Eczema/Dermatitis
Arm Type
Experimental
Arm Description
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 antipruritic efficacy and there is no safety concern.
Arm Title
Desloratadine: Dermal Puritus
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Desloratadine 5 mg
Intervention Description
Desloratadine 5 mg/day: one 5-mg tablet taken orally once daily in the evening for up to 12 weeks (Desloratadine 10 mg/day: two 5-mg tablets taken orally once daily in the evening for up to 8 weeks)
Primary Outcome Measure Information:
Title
Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Week 2
Description
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.
Time Frame
Baseline Visit and Week 2 Visit
Title
Percentage of Participants Who Experienced at Least One Adverse Event (AE)
Description
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 14 weeks (Up to 2 weeks after last dose dose of study drug)
Title
Percentage of Participants Who Discontinued Study Drug Due to an AE
Description
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 12 weeks
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline Visit and Day 3 Visit, Week 1 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit
Title
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
Description
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.
Time Frame
Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit
Title
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
Description
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.
Time Frame
Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Eczema/dermatitis (acute eczema, chronic eczema, contact dermatitis, atopic dermatitis, nummular eczema, seborrheic dermatitis, asteatotic eczema, neurodermatitis, etc. among eczema/dermatitis for which the observation of pruritus is appropriate)
Dermal pruritus (generalized dermal pruritus, localized dermal pruritus)
Exclusion Criteria:
Hypersensitivity to antihistamines or ingredients of a study drug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
Citation
Furue M, Maeda Y, Oshima N, Hisada S. A Phase III clinical trial of desloratadine in Japanese subjects with eczema/dermatitis and cutaneous pruritus: An open label long-term trial. J Clin Therapeut Med. 2016;32(11):877-889.. [in Japanese] https://mol.medicalonline.jp/archive/search?jo=an9cltmd&ye=2016&vo=32&issue=11
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/study.html?id=4117-202&kw=4117-202&tab=access
Learn more about this trial
Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Eczema/Dermatitis and Dermal Pruritus (MK-4117-202)
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