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Fluticasone Versus Esomeprazole to Treat Eosinophilic Esophagitis

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ClinicalTrials.gov Identifier: NCT00895817
Recruitment Status : Completed
First Posted : May 8, 2009
Results First Posted : March 12, 2013
Last Update Posted : March 12, 2013
Information provided by (Responsible Party):
Fouad J. Moawad, Walter Reed Army Medical Center

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

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
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 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   21   21   42 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 38  (10)   38  (10)   38  (19) 
[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

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