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
  Hide Participant Flow

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


  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


  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
No text entered.


  More Information