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A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab

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ClinicalTrials.gov Identifier: NCT00123630
Recruitment Status : Completed
First Posted : July 25, 2005
Results First Posted : October 21, 2013
Last Update Posted : May 20, 2016
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
John C. Fang, M.D., University of Utah

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Esophagitis
Interventions: Drug: omalizumab
Drug: Placebo

  Participant Flow


  Baseline Characteristics

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 ]
  Show Outcome Measure 1


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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