An Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Eczema/Dermatitis and Dermal Pruritus (MK-4117-202) | RxWiki

An Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Eczema/Dermatitis and Dermal Pruritus (MK-4117-202)

Overview[ - collapse ][ - ]

Purpose	This is a efficacy and safety study of up to 12 weeks of desolatadine in Japanese participants with eczema/dermatitis and dermal pruritus.
Condition	Eczema Dermatitis Dermal Pruritus
Intervention	Drug: Desloratadine
Phase	Phase 3
Sponsor	Merck Sharp & Dohme Corp.
Responsible Party	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier	NCT01916980
First Received	August 2, 2013
Last Updated	April 3, 2014
Last verified	April 2014

Tracking Information[ + expand ][ + ]

First Received Date	August 2, 2013
Last Updated Date	April 3, 2014
Start Date	August 2013
Estimated Primary Completion Date	March 2014
Current Primary Outcome Measures	Change from Baseline in pruritus/itch score (sum of daytime and nighttime scores) assessed by investigator at Week 2 [Time Frame: Baseline and Week 2] [Designated as safety issue: No] Percentage of participants who experienced at least one adverse event [Time Frame: Up to 14 weeks] [Designated as safety issue: Yes] Percentage of participants who discontinued from study drug due to an adverse event [Time Frame: Up to 12 weeks] [Designated as safety issue: Yes]
Current Secondary Outcome Measures	Change from Baseline in pruritus/itch score (sum of daytime and nighttime scores) assessed by investigator [Time Frame: Baseline, Day 3, Week 1, Week 4, Week 6, Week 8, and Week 12] [Designated as safety issue: No] Number of participants with improvement in the Global Improvement Rate assessed by investigator [Time Frame: Baseline, Day 3, Week 1, Week 2, Week 4, Week 6, Week 8, and Week 12] [Designated as safety issue: No] Change from baseline in the degree of pruritus recorded by participants [Time Frame: Baseline, Day 3, Week 1, Week 2, Week 4, Week 6, Week 8, and Week 12] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	An 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.
Brief Summary	This is a efficacy and safety study of up to 12 weeks of desolatadine in Japanese participants with eczema/dermatitis and dermal pruritus.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 3
Study Design	Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Eczema Dermatitis Dermal Pruritus
Intervention	Drug: Desloratadine Desloratadine, 5 mg, orally, once daily, one 5-mg tablet in the evening for up to 12 weeks (Desloratadine, 10 mg/day, orally, once daily, two 5-mg tablets in the evening for up to 8 weeks)
Study Arm (s)	Experimental: desloratadine (5 mg or 10 mg) Desloratadine, 5 mg, orally, once daily, one 5-mg tablet in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day up to 10 mg/day (two 5 mg tablets in the evening), if criteria for dose up-titration are met and there is insufficient anti-pruritic efficacy and no safety concern

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	94
Estimated Completion Date	March 2014
Estimated Primary Completion Date	March 2014
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
Gender	Both
Ages	12 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Not Provided

Administrative Information[ + expand ][ + ]

NCT Number	NCT01916980
Other Study ID Numbers	4117-202
Has Data Monitoring Committee	No
Information Provided By	Merck Sharp & Dohme Corp.
Study Sponsor	Merck Sharp & Dohme Corp.
Collaborators	Not Provided
Investigators	Not Provided
Verification Date	April 2014