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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01916980
First received: August 2, 2013
Last updated: April 3, 2014
Last verified: April 2014
  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 Intervention Phase
Eczema
Dermatitis
Dermal Pruritus
Drug: Desloratadine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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 ]

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 ]

Enrollment: 94
Study Start Date: August 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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)

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01916980     History of Changes
Other Study ID Numbers: 4117-202
Study First Received: August 2, 2013
Last Updated: April 3, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Merck Sharp & Dohme Corp.:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

Additional relevant MeSH terms:
Dermatitis
Eczema
Pruritus
Skin Diseases
Skin Diseases, Eczematous
Skin Manifestations
Signs and Symptoms
Desloratadine
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents

ClinicalTrials.gov processed this record on July 22, 2014