Conditions: Urticaria
Keywords: 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
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 239
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks arm 2: Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks arm 3: Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks

Interventions: intervention 1: Desloratadine intervention 2: Placebo
Intervention descriptions: intervention 1: Desloratadine 5 mg tablets, given orally, once daily in the evening for 2 weeks intervention 2: Placebo tablets, given orally, once daily in the evening for 2 weeks

Protocol document: