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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: February 23, 2017
Last verified: February 2017
Results First Received: October 27, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, 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]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      10 100.0%      9 100.0%      12 100.0%      31 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      7  70.0%      7  77.8%      9  75.0%      23  74.2% 
Male      3  30.0%      2  22.2%      3  25.0%      8  25.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      10 100.0%      9 100.0%      12 100.0%      31 100.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
       
Germany   10   9   12   31 


  Outcome Measures
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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:   Number of Participants With Abnormal Physical Examinations, Laboratory Assessments, Vital Signs, and Adverse Events   [ Time Frame: day 70 ]


  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: February 23, 2017