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
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: 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
Desloratadine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Histamine Antagonists
Histamine Agents

ClinicalTrials.gov processed this record on September 16, 2014