An Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Chronic Urticaria (MK-4117-201)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01916967
First received: August 2, 2013
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

This is a study to evaluate the efficacy and safety of desloratadine in Japanese participants with chronic urticaria.


Condition Intervention Phase
Urticaria
Drug: desloratadine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Multicentre, Parallel-group, Randomized, Placebo-controlled, Double-blind Clinical Trial to Study the Efficacy and Safety of MK-4117 in Japanese Subjects With Chronic Urticaria.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change from baseline in sum score of pruritus/itch and rash 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 4 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of participants who discontinued from study drug due to an adverse event [ Time Frame: Up to 2 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in sum score of pruritus/itch and rash assessed by investigator [ Time Frame: Baseline, Day 3, and Week 1 ] [ Designated as safety issue: No ]
  • Change from baseline in pruritus/itch score assessed by investigator [ Time Frame: Baseline, Day 3, Week 1, and Week 2 ] [ Designated as safety issue: No ]
  • Change from baseline in rash score assessed by investigator [ Time Frame: Baseline, Day 3, Week 1, and Week 2 ] [ Designated as safety issue: No ]
  • 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 investigator [ Time Frame: Baseline, Day 3, Week 1, and Week 2 ] [ Designated as safety issue: No ]
  • Change from baseline in pruritus/itch score reported in participant's diary [ Time Frame: Baseline, Day 3, Week 1, and Week 2 ] [ Designated as safety issue: No ]
  • Change from baseline in rash score reported in participant's diary [ Time Frame: Baseline, Day 3, Week 1, and Week 2 ] [ Designated as safety issue: No ]
  • Change from baseline in the Dermatology Life Quality Index (DLQI) score recorded by participants [ Time Frame: Baseline, Week 1, and Week 2 ] [ Designated as safety issue: No ]

Enrollment: 239
Study Start Date: August 2013
Study Completion Date: March 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: desloratadine (10 mg)
desloratadine 10 mg orally, once daily, two 5-mg tablets in the evening for 2 weeks
Drug: desloratadine
desloratadine, oral administration in the evening, dosage form is a 5-mg tablet
Experimental: desloratadine (5 mg)
desloratadine, 5 mg orally, once daily, one 5-mg tablet in the evening for 2 weeks
Drug: desloratadine
desloratadine, oral administration in the evening, dosage form is a 5-mg tablet
Placebo Comparator: Placebo
Matching placebo to desloratadine
Drug: Placebo
Placebo given orally, once daily, as two 5-mg tablets in the evening

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01916967     History of Changes
Other Study ID Numbers: 4117-201, MK-4117-201
Study First Received: August 2, 2013
Last Updated: March 27, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Merck Sharp & Dohme Corp.:
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

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Histamine Antagonists
Desloratadine
Histamine H1 Antagonists
Cholinergic Antagonists
Neurotransmitter Agents
Histamine H1 Antagonists, Non-Sedating
Histamine Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Cholinergic Agents

ClinicalTrials.gov processed this record on April 15, 2014