drugset / Trial / NCT01916967

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

NCT01916967

Phase 3 Completed 239 enrolled Organon and Co
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2013-08-27
Primary completion
2014-02-28
Completion
2014-03-13

Publications

  • Results Hide M, Maeda Y, Oshima N, Hisada S. A Phase III clinical trial of desloratadine in Japanese subjects with chronic urticaria: A randomized controlled trial. J Clin Therapeut Med. 2016;32(11):891-903.. [in Japanese] https://mol.medicalonline.jp/archive/search?jo=an9cltmd&ye=2016&vo=32&issue=11

Drugs

EvaluationDrugModalityDoseRoute
Subject Desloratadine Small molecule 5 mg Oral
Subject Desloratadine Small molecule 10 mg Oral

Indications