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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.
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01149395
First received: June 22, 2010
Last updated: October 29, 2012
Last verified: September 2012
History of Changes
  Purpose

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
Heartburn
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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01149395

Locations
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
Investigators
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
ClinicalTrials.gov 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:
Heartburn
Gastroesophageal Reflux Disease

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

ClinicalTrials.gov processed this record on June 18, 2013