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

Organon

Status and phase: Completed; Phase 3

Conditions: Urticaria

Treatments: Drug: Desloratadine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01916967

4117-201

132243 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 239 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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239 participants in 3 patient groups, including a placebo group

Desloratadine 5 mg

Experimental group

Description:

Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks

Treatment:

Drug: Placebo

Drug: Desloratadine

Desloratadine 10 mg

Experimental group

Description:

Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks

Treatment:

Drug: Desloratadine

Placebo

Placebo Comparator group

Description:

Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks

Treatment:

Drug: Placebo