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

• Status: Completed
• Trial end date: 2014-03-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Desloratadine; Histamine; Histamine H1 Antagonists; Histamine H1 Antagonists, Non-Sedating; Loratadine

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