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)