Status:
COMPLETED
Can E-cadherin Found in Tissue/Blood be Valuable in Identifying & Monitoring Patients With Post-proton Pump Inhibitor (PPI)-Responsive Heartburn
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
Heartburn
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The purpose of this research study is to determine in heartburn patients with nonerosive disease if detecting the presence of a fragment of the protein e-cadherin in esophageal epithelium or the amoun...
Detailed Description
The symptom of heartburn was once a reliable indicator of gastroesophageal reflux disease (GERD) and as such patients would predictably respond to acid inhibition. In the post-proton pump inhibitor (P...
Eligibility Criteria
Inclusion
- (all responses must be Yes)
- Between 18 and 75 years of age
- Male or non-pregnant, non-lactating female
- Willing and able to undergo endoscopy with biopsies and a blood draw
- Willing and able to discontinue use of PPIs for at least 1 month prior to the study start date
- Endoscopy-negative heartburn of moderate severity at least 3 times-a-week for 3 months
Exclusion
- (all responses must be No)
- History of:
- Barrett's Esophagus
- Erosive Esophagus
- Zollinger Ellison syndrome
- bleeding disorder
- upper gastrointestinal bleeding or malignancy
- esophageal motor disorder
- esophageal stricture
- esophageal varices
- Had the following surgeries:
- organ transplant
- gastric or esophageal surgery for the treatment of: Esophageal Cancer, Achalasia, Gastroesophageal Reflux Disease (GERD); i.e. Nissen Fundoplication
- Have any of the following:
- Current malabsorption
- inflammatory bowel disease
- severe heart-lung-liver or renal cerebrovascular disease
- known hypersensitivity to PPIs
- Currently taking any of the following medications:
- Quinidine
- quinine
- benzodiazepines
- antineoplastic agents
- dilantin
- warfarin
- non-steroidal anti-inflammatory drugs
- narcotics
- prostaglandins
- salicylates (except baby aspirin for cardiovascular protection)
- H2-receptor antagonists
- PPIs other than study agent
- steroids
- promotability drugs
- sucralfate
- KCl
- anti-tuberculosis medication
- oral biphosphonates
- drugs requiring acid for absorption (iron, ampicillin, digoxin and ketoconazole)
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01149395
Start Date
June 1 2010
End Date
April 1 2012
Last Update
December 19 2016
Active Locations (1)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599