At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 24 enrolled
Drug / intervention
Active +2 morebiological
Likely dose
Not stated in 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.
Multicenter Randomized, Double-blind, Placebo-controlled Parallel Clinical Trial to Assess Efficacy and Safety of Omalizumab (Xolair®) in a New Indication: Cholinergic Urticarial
Clinica Universidad de Navarra, Universidad de Navarra·interventional·Posted Dec 16, 2013·Updated Feb 12, 2019
In Brief
A Phase 2 clinical trial evaluating Active, Placebo, and 1 other intervention for Cholinergic Urticaria. Completed, enrolled 24 participants across 1 site.
Detailed Summary
To demonstrate the efficacy and safety of Omalizumab in a new indication, that is cholinergic urticaria.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCholinergic Urticaria
CountriesSpain
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 2013
Enrollment StartJan 2014
Primary CompletionSep 2016
Study CompletionJun 2017
TodayJul 2026
First PostedDec 16, 2013
Enrollment StartJan 1, 2014
Primary CompletionSep 1, 2016
Study CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 12.5 years ago
Interventions
Activebiological
Two injections will be administered every four weeks for four months, we will administer 4 doses within 16 weeks
Placebobiological
Two injections will be administered every four weeks for four months, we will administer 4 doses within 16 weeks
Open labeledbiological
Two injections will be administered every four weeks for 8 months, we will administer 4 doses within 32 weeks