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A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
John C. Fang, M.D., University of Utah
ClinicalTrials.gov Identifier:
NCT00123630
First received: July 21, 2005
Last updated: May 18, 2016
Last verified: March 2016
History of Changes
Results First Received: September 5, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Esophagitis
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Placebo 150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
Omalizumab Xolair (Omalizumab)150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).

Participant Flow:   Overall Study
    Placebo   Omalizumab
STARTED   15   15 
COMPLETED   15   15 
NOT COMPLETED   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.
No text entered.

Reporting Groups
  Description
Placebo Placebo 150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
Omalizumab Xolair (Omalizumab)150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
Total Total of all reporting groups

Baseline Measures
   Placebo   Omalizumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 15   15   30 
Age 
[Units: Participants]
 		     
<=18 years   0   0   0 
Between 18 and 65 years   15   15   30 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation) 		 28  (6)   32  (12)   30  (10) 
Gender 
[Units: Participants]
 		     
Female   5   3   8 
Male   10   12   22 
Region of Enrollment 
[Units: Participants]
 		     
United States   15   15   30 


  Outcome Measures

1.  Primary:   Change in Eosinophil Numbers Per High Power Field Proximally and Distally Between Baseline and Post-treatment and Between Both Groups   [ Time Frame: 16 weeks ]
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  Serious Adverse Events
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  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   2%  

Reporting Groups
  Description
Placebo Placebo 150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
Omalizumab Xolair (Omalizumab)150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).

Other Adverse Events
    Placebo   Omalizumab
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   0/15 (0.00%)   0/15 (0.00%) 



  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
small numbers enrolled


  More Information
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