Study of the Efficiency of Esophageal Dilation on Patient With Eosinophilic Esophagitis (EOE)

This study has been completed.
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Michael Vaezi, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00880906
First received: August 25, 2008
Last updated: April 29, 2014
Last verified: July 2013
Results First Received: March 27, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Suspected Eosinophilic Esophagitis
Interventions: Procedure: Esophageal dilation
Drug: Steroid and Proton Pump Inhibitor Therapy

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group A Drug Therapy Plus Dilation

Group A receives steroids and PPI, (SOC) and esophageal dilation.

Esophageal dilation: The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation.

Group B Drug Therapy Only Receives steroids and PPI only- Does not have esophageal dilation.

Participant Flow:   Overall Study
    Group A Drug Therapy Plus Dilation     Group B Drug Therapy Only  
STARTED     29     21  
COMPLETED     17     14  
NOT COMPLETED     12     7  
Lost to Follow-up                 0                 1  
Did not meet criteria following patholog                 12                 6  



  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
Group A Receives Routine Care and Esophageal Dilatation

Group A receives steroids and PPI, (SOC) and esophageal dilation.

Esophageal dilation: The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation.

Group B Receives SOC Only Receives steroids and PPI only- Does not have esophageal dilation.
Total Total of all reporting groups

Baseline Measures
    Group A Receives Routine Care and Esophageal Dilatation     Group B Receives SOC Only     Total  
Number of Participants  
[units: participants]
  29     21     50  
Age  
[units: Years]
Median ( Full Range )
  35  
  ( 19 to 61 )  
  32  
  ( 20 to 69 )  
  33  
  ( 19 to 69 )  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     29     20     49  
>=65 years     0     1     1  
Gender  
[units: participants]
     
Female     13     9     22  
Male     16     12     28  
Region of Enrollment  
[units: participants]
     
United States     29     21     50  



  Outcome Measures

1.  Primary:   Percent Change From Baseline in Dysphagia Score in Patients With Eosinophilic Esophagitis (EE)   [ Time Frame: 60 days ]

2.  Secondary:   Immunological Assessment Into the Etiology of Eosinophilic Esophagitis   [ Time Frame: 60 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
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  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.


Results Point of Contact:  
Name/Title: Michael Vaezi, MD, PhD
Organization: Vanderbilt University
phone: 615-322-3739
e-mail: michael.vaezi@vanderbilt.edu


No publications provided


Responsible Party: Michael Vaezi, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00880906     History of Changes
Other Study ID Numbers: 080741
Study First Received: August 25, 2008
Results First Received: March 27, 2014
Last Updated: April 29, 2014
Health Authority: United States: Institutional Review Board