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
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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
Subjects with symptoms of esophageal dysfunction were recruited from the GI clinic of Walter Reed Army Medical Center. Recruitment dates were from 2008-2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects with a confirmed diagnosis of EE based on symptoms and tissue biopsies were offered enrollment.All subject underwent 24-hour pH studies to stratify GERD positive and GERD negative. A computer generated list of random numbers was then used to separate patients into two equal treatment groups (esomeprazole and fluticasone proprionate).

Reporting Groups
  Description
Esomeprazole Esomeprazole : 40 mg once daily for 8 weeks
Swallowed Fluticasone Swallowed fluticasone : 440 µg twice daily for 8 weeks

Participant Flow:   Overall Study
    Esomeprazole     Swallowed Fluticasone  
STARTED     21     21  
COMPLETED     21     21  
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
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 posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

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


  Serious Adverse Events


  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   0%  

Reporting Groups
  Description
Esomeprazole Esomeprazole : 40 mg once daily for 8 weeks
Swallowed Fluticasone Swallowed fluticasone : 440 µg twice daily for 8 weeks

Other Adverse Events
    Esomeprazole     Swallowed Fluticasone  
Total, other (not including serious) adverse events      
# participants affected / at risk     0/21     0/21  



  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


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
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Fouad J Moawad
Organization: Walter Reed Army Medical Center
phone: (301) 295-4600
e-mail: fouad.moawad@us.army.mil


No publications provided


Responsible Party: Fouad J. Moawad, Walter Reed Army Medical Center
ClinicalTrials.gov Identifier: NCT00895817     History of Changes
Other Study ID Numbers: 08-14045
Study First Received: May 6, 2009
Results First Received: December 28, 2012
Last Updated: March 11, 2013
Health Authority: United States: Federal Government