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NCT01292473 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)
A Phase 3 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 3
- Development phase
- 323
- Enrollment target
NCT01292473 is a Phase 3 study that has completed, run by Genentech. The registered enrollment target is 323 participants.
The verdict
NCT01292473, a Phase 3 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 323 participants
- Enrollment target
Study Summary
The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged 12-75 who have been diagnosed with refractory CIU and who remain symptomatic despite standard-dosed H1 antihistamine treatment.
Interventions
- DRUG Placebo
- DRUG Omalizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 323 participants |
| Start Date | 2011-03 |
| Est. Completion | 2012-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01292473
The ClinicalTrials.gov registry entry for NCT01292473 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 323 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01292473 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01292473 about?
NCT01292473 is a clinical study titled "A Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)". The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged 12-75 who have been diagnosed wi...
What is the current status of trial NCT01292473?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 323 participants. The study started on 2011-03. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01292473?
The interventions under investigation include: Placebo (DRUG), Omalizumab (DRUG).
Who is sponsoring clinical trial NCT01292473?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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