|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
4 March 2013 |
|
Main ID: |
NCT01404832 |
|
Date of registration:
|
27/07/2011 |
|
Primary sponsor: |
|
|
Public title:
|
The Frequency of Eosinophilic Esophagitis in Patients With Heartburn That is Refractory to Proton Pump Inhibitors
|
|
Scientific title:
|
The Frequency of Eosinophilic Esophagitis in Patients With Heartburn That is Refractory to Proton Pump Inhibitors |
|
Date of first enrolment:
|
October 2007 |
|
Target sample size:
|
102 |
|
Recruitment status: |
Terminated |
|
URL:
|
http://clinicaltrials.gov/show/NCT01404832 |
|
Study type:
|
Interventional |
|
Study design:
|
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Stuart J Spechler, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Dallas VA Medical Center |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:Male and female patients ages 18 years and older who are referred to
the Division of Gastroenterology at the Dallas VA Medical Center for the evaluation of
heartburn that is refractory to PPI therapy
Exclusion Criteria:
1. Patients unwilling or unable to provide informed consent.
2. Allergy to lansoprazole.
3. Patients taking warfarin.
4. Coagulopathy that precludes safe biopsy of the esophagus.
5. Comorbidity that precludes safe participation in the study.
6. Pregnancy.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Eosinophilic Esophagitis
|
|
Gastroesophageal Reflux Disease
|
|
Intervention(s)
|
|
Drug: Treat with lansoprazole 30 mg BID for 2 weeks, endoscopic examination with esophageal biopsy for patients with persistent symptoms
|
|
Primary Outcome(s)
|
|
Number of Participants With Eosinophilic Esophagitis
[Time Frame: 8 weeks]
|
|
Secondary Outcome(s)
|
|
Number of Patients Who Had Resolution of Heartburn With Lansoprazole
[Time Frame: After 8 weeks of treatment]
|
|
Secondary ID(s)
|
|
VAIRB06-093
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|