Trial · NCT00890162
A Randomized, Double-Blind, Placebo-Controlled Study of Omalizumab for Idiopathic Anaphylaxis
NCT00890162, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2019-07-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Randomized, Double-Blind, Placebo-Controlled Study of Omalizumab for Idiopathic Anaphylaxis. Trials, record NCT00890162. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00890162
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized, Double-Blind, Placebo-Controlled Study of Omalizumab for Idiopathic Anaphylaxis
- NCT number
- NCT00890162
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 16 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Anaphylaxis, Hypotension, Bronchospasm, Angioedema
- Interventions
- Epinephrine, Omalizumab (Xolair), Placebos
- First posted
- 2009-04-29
- Last updated
- 2019-07-01
- Results first posted
- 2019-07-01
- Limitations and caveats
Although we received multiple inquiries for this study, it was difficult to find subjects who met all eligibility criteria and who were also willing to participate in a double-blind placebo-controlled trial.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Reduction in the Number and Timing of Anaphylactic Events in Subjects With a History of Frequent Idiopathic Anaphylaxis. | 6 months | To determine if treatment with omalizumab over 6 months will produce a reduction in the number and timing of anaphylactic events in subjects with a history of frequent idiopathic anaphylaxis. Ordinal outcome of participants based on number of events in 6 months after baseline and timing of first event. Events were calculated based on detailed event logs maintained by the patients and collected every 2-4 weeks based on injection schedule. Mean percent change in number of events experienced while on study agent for each subject and results presented as a group. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Reduction in the Number and Timing of Anaphylactic Events in Subjects With a History of Frequent Idiopathic Anaphylaxis. | 6 months | percentage of change of events | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Reduction in the Number and Timing of Anaphylactic Events in Subjects With a History of Frequent Idiopathic Anaphylaxis. | Omalizumab | 32 | 95% Confidence Interval 6 to 57 | percentage of change of events | |
| Reduction in the Number and Timing of Anaphylactic Events in Subjects With a History of Frequent Idiopathic Anaphylaxis. | Placebo | 6 | 95% Confidence Interval -38 to 50 | percentage of change of events |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Omalizumab | 8 | |
| Overall Study | STARTED | Placebo | 8 | |
| Overall Study | COMPLETED | Omalizumab | 6 | |
| Overall Study | COMPLETED | Placebo | 7 | |
| Overall Study | NOT COMPLETED | Omalizumab | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events138
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Lymphadenopathy | Blood and lymphatic system disorders | Omalizumab | 1 | 8 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Placebo | 0 | 8 | |
| other | Chest discomfort | Cardiac disorders | Omalizumab | 1 | 8 | |
| other | Chest discomfort | Cardiac disorders | Placebo | 0 | 8 | |
| other | Chest pain | Cardiac disorders | Omalizumab | 1 | 8 | |
| other | Chest pain | Cardiac disorders | Placebo | 0 | 8 | |
| other | Dizziness | Cardiac disorders | Omalizumab | 1 | 8 | |
| other | Dizziness | Cardiac disorders | Placebo | 2 | 8 | |
| other | Dyspnoea | Cardiac disorders | Omalizumab | 2 | 8 | |
| other | Dyspnoea | Cardiac disorders | Placebo | 1 | 8 |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Omalizumab | 0 | 8 |
| Total, all-cause mortality | Placebo | 0 | 8 |
| Total, other adverse events | Omalizumab | 8 | 8 |
| Total, other adverse events | Placebo | 8 | 8 |
| Total, serious adverse events | Omalizumab | 3 | 8 |
| Total, serious adverse events | Placebo | 2 | 8 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Omalizumab vs Placebo: deaths from any cause | Trial comparisons |
| Omalizumab vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00890162
GET https://conductscience.org/api/trials/v1/NCT00890162/events?page=2