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Trial record 1 of 1 for:    roy orlando and e-cadherin
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01149395
Recruitment Status : Completed
First Posted : June 23, 2010
Last Update Posted : December 19, 2016
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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 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 or disease Intervention/treatment Phase
Heartburn Gastroesophageal Reflux Disease Drug: Dexlansoprazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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?
Study Start Date : June 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD Heartburn

Arm Intervention/treatment
Experimental: Dexlansoprazole Drug: Dexlansoprazole
Dosage: 30 mg once per day for 4 weeks by mouth
Other Name: Kapidex

Primary Outcome Measures :
  1. Dexlansoprazole [ Time Frame: 4 weeks ]
    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 :
  1. Dexlansoprazole [ Time Frame: 4 weeks ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01149395

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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
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Principal Investigator: Roy C Orlando, MD University of North Carolina, Chapel Hill
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01149395    
Other Study ID Numbers: 10-0417
First Posted: June 23, 2010    Key Record Dates
Last Update Posted: December 19, 2016
Last Verified: December 2016
Keywords provided by University of North Carolina, Chapel Hill:
Gastroesophageal Reflux Disease
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action