NCT01916980

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

A Phase III, Multicenter, Open-Label Long-Term Trial to Study the Efficacy and Safety of MK-4117 in Japanese Subjects With Eczema/Dermatitis and Dermal Pruritus.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Eczema
• Dermatitis
• Dermal Pruritus

Interventions

Type	Name	Description
DRUG	Desloratadine 5 mg	Desloratadine 5 mg/day: one 5-mg tablet taken orally once daily in the evening for up to 12 weeks (Desloratadine 10 mg/day: two 5-mg tablets taken orally once daily in the evening for up to 8 weeks)

Timeline

• Start date: 2013-08-27
• Primary completion: 2014-03-08
• Completion: 2014-03-22
• First posted: 2013-08-06
• Last updated: 2024-06-18
• Results posted: 2014-11-19