Overview

Can E-cadherin Found in Tissue/Blood be Valuable in Identifying & Monitoring Patients With Post-proton Pump Inhibitor (PPI)-Responsive Heartburn

Status:
Completed
Trial end date:
2012-04-01
Target enrollment:
0
Participant gender:
All
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 amount of fragments of e-cadherin in blood can be used to monitor healing of esophagitis treated with a proton pump inhibitor (PPI). The hypothesis is that the presence of fragments of e-cadherin in esophageal epithelium or the amount of fragments of e-cadherin in blood can you useful as a biomarker for the healing of esophagitis in patients successfully treated with a PPI.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of North Carolina, Chapel Hill
Treatments:
Dexlansoprazole
Lansoprazole
Proton Pump Inhibitors
Criteria
Inclusion Criteria: (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 Criteria:(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)