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Cold Urticaria Treatment With Xolair (CUTEX)

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Martin Metz, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01580592
First received: April 18, 2012
Last updated: September 9, 2016
Last verified: September 2016
Results First Received: October 27, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Cold Contact Urticaria
Interventions: Drug: Omalizumab
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Omalizumab 150mg Omalizumab: 150mg, s.c., every 4 weeks
Omalizumab 300mg Omalizumab: 300mg, s.c., every 4 weeks
Placebo Placebo: Placebo, s.c., every 4 weeks

Participant Flow:   Overall Study
    Omalizumab 150mg   Omalizumab 300mg   Placebo
STARTED   10   9   12 
COMPLETED   10   9   12 
NOT COMPLETED   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention-to-treat

Reporting Groups
  Description
Omalizumab 150mg Omalizumab: 150mg, s.c., every 4 weeks
Omalizumab 300mg Omalizumab: 300mg, s.c., every 4 weeks
Placebo Placebo: Placebo, s.c., every 4 weeks
Total Total of all reporting groups

Baseline Measures
   Omalizumab 150mg   Omalizumab 300mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   9   12   31 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   10   9   12   31 
>=65 years   0   0   0   0 
Gender 
[Units: Participants]
       
Female   7   7   9   23 
Male   3   2   3   8 
Ethnicity (NIH/OMB) 
[Units: Participants]
       
Hispanic or Latino   0   0   0   0 
Not Hispanic or Latino   10   9   12   31 
Unknown or Not Reported   0   0   0   0 
Region of Enrollment 
[Units: Participants]
       
Germany   10   9   12   31 


  Outcome Measures

1.  Primary:   Change in Critical Temperature Thresholds (CTT) From Baseline to Day 70 After Treatment With Omalizumab Compared to Placebo   [ Time Frame: day 70 ]

2.  Secondary:   Safety of Patients Treated With Omalizumab   [ Time Frame: day 70 ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Professor Dr. Martin Metz
Organization: Charité – University of Berlin; Dpt. of Dermatology and Allergy
phone: +49 30 450 518 159
e-mail: martin.metz@charite.de



Responsible Party: Martin Metz, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01580592     History of Changes
Other Study ID Numbers: CIGE025EDE14T
Study First Received: April 18, 2012
Results First Received: October 27, 2015
Last Updated: September 9, 2016
Health Authority: Germany: Paul-Ehrlich-Institut