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Fluticasone Versus Esomeprazole to Treat Eosinophilic Esophagitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fouad J. Moawad, Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00895817
First received: May 6, 2009
Last updated: March 11, 2013
Last verified: March 2013
Results First Received: December 28, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Eosinophilic Esophagitis
Interventions: Drug: Swallowed fluticasone
Drug: Esomeprazole

  Participant Flow


  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
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  
Number of Participants  
[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.   Safety Issue:   No

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


  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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