Trial · NCT01580592

Cold Urticaria Treatment With Xolair

NCT01580592, Phase 2, Completed, Charite University, Berlin, Germany; results first posted 2016-02-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Cold Urticaria Treatment With Xolair. Trials, record NCT01580592. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01580592

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Cold Urticaria Treatment With Xolair
NCT number: NCT01580592
Status: Completed
Phases: Phase 2
Enrollment: 31 participants, actual
Lead sponsor: Charite University, Berlin, Germany
Conditions: Cold Contact Urticaria
Interventions: Omalizumab, Omalizumab, Placebo
First posted: 2012-04-19
Last updated: 2017-04-07
Results first posted: 2016-02-15

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Critical Temperature Thresholds (CTT) From Baseline to Day 70 After Treatment With Omalizumab Compared to Placebo	day 70	The primary efficacy outcome was the change in trigger thresholds from baseline to week ten using TempTest® to assess critical temperature thresholds in °C.
Secondary	Number of Participants With Abnormal Physical Examinations, Laboratory Assessments, Vital Signs, and Adverse Events	day 70	This includes physical examination, routine safety laboratory assessments, vital signs and adverse event reporting

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Critical Temperature Thresholds (CTT) From Baseline to Day 70 After Treatment With Omalizumab Compared to Placebo	day 70	female and male	degree celcius	MEAN
SECONDARY	Number of Participants With Abnormal Physical Examinations, Laboratory Assessments, Vital Signs, and Adverse Events	day 70		participants	NUMBER

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Critical Temperature Thresholds (CTT) From Baseline to Day 70 After Treatment With Omalizumab Compared to Placebo	Omalizumab 150mg	-10.6	Standard Deviation 7.6	degree celcius
Change in Critical Temperature Thresholds (CTT) From Baseline to Day 70 After Treatment With Omalizumab Compared to Placebo	Omalizumab 300mg	-10.4	Standard Deviation 9.4	degree celcius
Change in Critical Temperature Thresholds (CTT) From Baseline to Day 70 After Treatment With Omalizumab Compared to Placebo	Placebo	-0.3	Standard Deviation 3.9	degree celcius
Number of Participants With Abnormal Physical Examinations, Laboratory Assessments, Vital Signs, and Adverse Events	Omalizumab 150mg	7		participants
Number of Participants With Abnormal Physical Examinations, Laboratory Assessments, Vital Signs, and Adverse Events	Omalizumab 300mg	7		participants
Number of Participants With Abnormal Physical Examinations, Laboratory Assessments, Vital Signs, and Adverse Events	Placebo	9		participants

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Omalizumab 150mg	10
Overall Study	STARTED	Omalizumab 300mg	9
Overall Study	STARTED	Placebo	12
Overall Study	COMPLETED	Omalizumab 150mg	10
Overall Study	COMPLETED	Omalizumab 300mg	9
Overall Study	COMPLETED	Placebo	12
Overall Study	NOT COMPLETED	Omalizumab 150mg	0
Overall Study	NOT COMPLETED	Omalizumab 300mg	0
Overall Study	NOT COMPLETED	Placebo	0

Source ClinicalTrials.gov

Adverse events6

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
other	Headache	General disorders	Omalizumab 150mg	2	10
other	Headache	General disorders	Omalizumab 300mg	2	9
other	Headache	General disorders	Placebo	4	12
other	upper respiratory tract infection	Infections and infestations	Omalizumab 150mg	2	10
other	upper respiratory tract infection	Infections and infestations	Omalizumab 300mg	2	9
other	upper respiratory tract infection	Infections and infestations	Placebo	4	12

Source ClinicalTrials.gov

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Omalizumab 150mg
Total, all-cause mortality	Omalizumab 300mg
Total, all-cause mortality	Placebo
Total, other adverse events	Omalizumab 150mg	4	10
Total, other adverse events	Omalizumab 300mg	4	9
Total, other adverse events	Placebo	5	12
Total, serious adverse events	Omalizumab 150mg	0	10
Total, serious adverse events	Omalizumab 300mg	0	9
Total, serious adverse events	Placebo	0	12

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28389393	DERIVED

Source PubMed

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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01580592

GET https://conductscience.org/api/trials/v1/NCT01580592/registered

API reference For AI assistants