Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
15 participants
INTERVENTIONAL
2022-01-01
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Omalizumab
Omalizumab
omalizumab 300mg SQ every 4 weeks as part of standard of care
Interventions
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Omalizumab
omalizumab 300mg SQ every 4 weeks as part of standard of care
Eligibility Criteria
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Inclusion Criteria
* Symptoms not controlled with standard dose antihistamines (loratadine 10mg daily, desloratadine 5mg daily, fexofenadine 180mg daily, cetirizine 10mg daily, or levocetirizine 5mg daily)
* Planned initiation of treatment with omalizumab (Xolair) as part of standard of care for antihistamine-refractory urticaria
Exclusion Criteria
* Use of systemic steroids in the past 1 month prior to beginning the study
* Use of omalizumab in the past 3 months prior to beginning the study
* Use of any investigational agent in the past 30 days
* Untreated intercurrent illness
* Severe Asthma
* Primary diagnosis of flushing
18 Years
75 Years
ALL
Yes
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Jenny Stitt, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado Anschutz
Aurora, Colorado, United States
Countries
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Other Identifiers
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18-0850
Identifier Type: -
Identifier Source: org_study_id
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