drugset / Trial / NCT01916980

Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Eczema/Dermatitis and Dermal Pruritus (MK-4117-202)

NCT01916980

Phase 3 Completed 94 enrolled Organon and Co
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is an efficacy and safety study of up to 12 weeks of desloratadine in Japanese participants with eczema/dermatitis and dermal pruritus. The primary hypothesis of this study is that the sum of the daytime and nighttime pruritus/itch scores for both the eczema/dermatitis group and the dermal pruritus group will be significantly improved at Week 2 compared to Baseline.

Timeline

Start
2013-08-27
Primary completion
2014-03-08
Completion
2014-03-22

Publications

  • Results Furue M, Maeda Y, Oshima N, Hisada S. A Phase III clinical trial of desloratadine in Japanese subjects with eczema/dermatitis and cutaneous pruritus: An open label long-term trial. J Clin Therapeut Med. 2016;32(11):877-889.. [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