CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 94 enrolled
Drug / intervention
Desloratadine 5 mgdrug
Likely dose
Desloratadine 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01916980
NCT01916980Phase 3Completed
CompareCT.gov

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.

Organon and Co·interventional·Posted Aug 6, 2013·Updated Jun 18, 2024

In Brief

A Phase 3 clinical trial evaluating Desloratadine 5 mg for Eczema and 2 related conditions. Completed, enrolled 94 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEczema, Dermatitis, Dermal Pruritus
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 6, 2013
Enrollment StartAug 27, 2013
Primary CompletionMar 8, 2014
Study CompletionMar 22, 2014
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 12.9 years ago

Interventions

Desloratadine 5 mgdrug

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)