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The Role Of Gastroesophageal Reflux Disease (GERD) in Eosinophilic Esophagitis

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Amy Foxx-Orenstein, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00728481
First received: July 15, 2008
Last updated: November 8, 2012
Last verified: November 2012
Results First Received: October 5, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Eosinophilic Esophagitis
Gastroesophageal Reflux Disease
EE
GERD
Interventions: Drug: Esomeprazole
Drug: Budesonide

  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 a clinical diagnosis of Eosinophilic Esophagitis (EE) were recruited by mail using a Mayo Clinic proprietary database and also by direct contact in the Mayo Clinic Esophageal Diseases speciality clinic in Rochester, MN. Subjects were enrolled from 3/2009 to 8/2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients with esophageal eosinophilic infiltration of greater than or equal to 15 eos/hpf as determined by 4 biopsies of the esophagus, then underwent a 24-hour transnasal catheter-based ambulatory pH study to determine amount of distal esophageal acid exposure, and were placed in one of 2 treatment arms based on positive or negative pH results.

Reporting Groups
  Description
Esomeprazole Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
Budesonide Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)

Participant Flow:   Overall Study
    Esomeprazole     Budesonide  
STARTED     19     32  
COMPLETED     18     28  
NOT COMPLETED     1     4  
Withdrawal by Subject                 0                 1  
Adverse Event                 0                 1  
Study medication non-compliance                 0                 2  
Incorrectly assigned to opposite arm                 1                 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 Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
Budesonide Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
Total Total of all reporting groups

Baseline Measures
    Esomeprazole     Budesonide     Total  
Number of Participants  
[units: participants]
  19     32     51  
Age  
[units: years]
Mean ± Standard Deviation
  47.5  ± 14.9     33.7  ± 10.4     39  ± 13.9  
Gender  
[units: participants]
     
Female     7     13     20  
Male     12     19     31  
Region of Enrollment  
[units: participants]
     
United States     19     32     51  
Mean number of eosinophils per high powered field in esophagus [1]
[units: eos/hpf]
Mean ± Standard Deviation
  35.6  ± 24.7     46.7  ± 26.5     41.2  ± 27.7  
Endoscopic evidence of GERD [2]
[units: Participants]
     
Multiple rings (felinization or corrugations)     14     18     32  
Hiatal hernia     15     10     25  
Erosive esophagitis     7     2     9  
Number of participants with frequent GERD/dysphagia symptoms [3]
[units: participants]
     
Frequent symptoms     15     0     15  
No or infrequent symptoms     3     17     20  
No symptoms     0     15     15  
[1] Mean eosinophilic density per high power field [eos/hpf] (at 400 x magnification) of four esophageal biopsies each taken from the proximal & distal esophagus at some point 18 months or less prior to study enrollment.
[2] Participants could have had more than one symptom of GERD, or no symptoms of GERD.
[3]

The GERD portion of the Mayo Dysphagia Questionnaire-30 day (MDQ-30) was used to evaluate the frequency of GERD symptoms. The Mayo Dysphagia Questionnaire is a validated 28 item instrument; 0 = no dysphagia, higher levels indicate greater dysphagia severity.

Note: 18 of the 19 participants with GERD completed the questionnaire.




  Outcome Measures
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1.  Primary:   Histological Response to Treatment   [ Time Frame: Baseline, 6 months ]

2.  Primary:   Symptomatic Response to Treatment   [ Time Frame: Baseline, 6 months ]

3.  Secondary:   Change in Dysphagia Symptoms in Subjects With Histological Response to Treatment   [ Time Frame: Baseline, 6 months ]

4.  Secondary:   Change in Dysphagia Symptoms in Subjects With Non-significant Histological Response to Treatment   [ Time Frame: Baseline, 6 months ]

5.  Secondary:   Participants With Presence of Esophageal Rings/Furrows at Six Month Endoscopy   [ Time Frame: Baseline, 6 months ]

6.  Secondary:   Participants With Presence of Erosive Esophagitis at Six Month Endoscopy   [ Time Frame: Baseline, 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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

The index endoscopy was obtained solely for clinical reasons and could have been done as long as 18 months prior to study enrollment.

A single question on the dysphagia questionnaire was used to assess dysphagia symptom response.



  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Amy Foxx-Orenstein, D.O., Associate Prof. of Medicine, College of Medicine
Organization: Mayo Clinic
phone: 480-301-8806
e-mail: foxx-orenstein.amy@mayo.edu


Publications of Results:

Responsible Party: Amy Foxx-Orenstein, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00728481     History of Changes
Other Study ID Numbers: 07-006685
Study First Received: July 15, 2008
Results First Received: October 5, 2012
Last Updated: November 8, 2012
Health Authority: United States: Food and Drug Administration