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

Last updated: June 5, 2024
Sponsor: Organon and Co
Overall Status: Completed

Phase

3

Condition

Urticaria

Hives (Urticaria)

Treatment

Desloratadine

Placebo

Clinical Study ID

NCT01916967
4117-201
132243
  • Ages > 12
  • All Genders

Study Summary

This is a study to evaluate the efficacy and safety of desloratadine (MK-4117) in Japanese participants with chronic urticaria. The primary hypothesis is that the efficacy of desloratadine 10 mg and 5 mg is superior to placebo as based on the change from Baseline in the sum score of pruritus/itch and rash as assessed by the Investigator at Week 2.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Chronic urticaria [rash (erythema, wheal) for more than 1 month without any knowncause]

  • Out-patient

Exclusion

Exclusion Criteria:

  • Stimulation-induced urticaria [physical urticaria (e.g. cold, solar, and heaturticaria), cholinergic urticaria, contact urticaria)]

  • Hypersensitivity to antihistamines or ingredients of a study drug

Study Design

Total Participants: 239
Treatment Group(s): 2
Primary Treatment: Desloratadine
Phase: 3
Study Start date:
August 27, 2013
Estimated Completion Date:
March 13, 2014

Connect with a study center

  • MSD K.K.

    Chiyoda-Ku, Tokyo, 102-8667
    Japan

    Site Not Available

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