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Fluticasone Versus Esomeprazole to Treat Eosinophilic Esophagitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00895817
First Posted: May 8, 2009
Last Update Posted: March 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Fouad J. Moawad, Walter Reed Army Medical Center
Results First Submitted: December 28, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition: Eosinophilic Esophagitis
Interventions: Drug: Swallowed fluticasone
Drug: Esomeprazole

  Participant Flow


  Baseline Characteristics
  Hide 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.
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Reporting Groups
  Description
Esomeprazole Esomeprazole : 40 mg once daily for 8 weeks
Swallowed Fluticasone Swallowed fluticasone : 440 µg twice daily for 8 weeks
Total Total of all reporting groups

Baseline Measures
   Esomeprazole   Swallowed Fluticasone   Total 
Overall Participants Analyzed 
[Units: Participants]
 21   21   42 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   21   21   42 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 38  (10)   38  (10)   38  (19) 
Gender 
[Units: Participants]
     
Female   2   2   4 
Male   19   19   38 
Region of Enrollment 
[Units: Participants]
     
United States   21   21   42 


  Outcome Measures

1.  Primary:   Number of Participants Who Responded   [ Time Frame: 8 weeks ]

2.  Secondary:   Symptom Score   [ Time Frame: 8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Endoscopic Change   [ Time Frame: 8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
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  More Information