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

This study has been completed.
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill Identifier:
First received: June 22, 2010
Last updated: October 29, 2012
Last verified: September 2012

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.

Condition Intervention Phase
Gastroesophageal Reflux Disease
Drug: Dexlansoprazole
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Can Detection of Fragments of Cleaved E-cadherin in Tissue and/or Blood be of Value for Identifying and Monitoring Patients With PPI-responsive Heartburn?

Resource links provided by NLM:

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Dexlansoprazole [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Primary outcome measure: To determine whether detection of cleaved fragments of e-cadherin in esophageal biopsies and in serum can discriminate between nonerosive patients with PPI-responsive and PPI-refractory heartburn.

Secondary Outcome Measures:
  • Dexlansoprazole [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    To determine whether serum levels of N-terminal fragments of e-cadherin can be useful to monitor esophageal healing in patients with nonerosive PPI-responsive heartburn.

Enrollment: 40
Study Start Date: June 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexlansoprazole Drug: Dexlansoprazole
Dosage: 30 mg once per day for 4 weeks by mouth
Other Name: Kapidex

  Show Detailed Description


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Please refer to this study by its identifier: NCT01149395

United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Principal Investigator: Roy C Orlando, MD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: University of North Carolina, Chapel Hill Identifier: NCT01149395     History of Changes
Other Study ID Numbers: 10-0417
Study First Received: June 22, 2010
Last Updated: October 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Gastroesophageal Reflux Disease

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Proton Pump Inhibitors
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 14, 2014