At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 239 enrolled
Drug / intervention
Desloratadine +1 moredrug
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.
A Phase III Multicentre, Parallel-group, Randomized, Placebo-controlled, Double-blind Clinical Trial to Study the Efficacy and Safety of MK-4117 in Japanese Subjects With Chronic Urticaria.
In Brief
A Phase 3 clinical trial evaluating Desloratadine and Placebo for Urticaria. Completed, enrolled 239 participants.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrticaria
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 2013
Enrollment StartAug 2013
Primary CompletionFeb 2014
Study CompletionMar 2014
TodayJul 2026
First PostedAug 6, 2013
Enrollment StartAug 27, 2013
Primary CompletionFeb 28, 2014
Study CompletionMar 13, 2014
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 12.9 years ago
Interventions
Desloratadinedrug
Desloratadine 5 mg tablets, given orally, once daily in the evening for 2 weeks
Placebodrug
Placebo tablets, given orally, once daily in the evening for 2 weeks