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

NCT01149395 | Completed Phase 1

• 1 other identifier: 10-0417
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Heartburn; Gastroesophageal Reflux Disease

Keywords

Heartburn; Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (1)

• Dexlansoprazole

  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.

  4 weeks

Secondary Outcomes (1)

• Dexlansoprazole

  4 weeks

Study Arms (1)

Dexlansoprazole

EXPERIMENTAL

Drug: Dexlansoprazole

Interventions

Dexlansoprazole DRUG

Dosage: 30 mg once per day for 4 weeks by mouth

Also known as: Kapidex

Dexlansoprazole

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Heartburn; Gastroesophageal Reflux

Interventions

Dexlansoprazole; Lansoprazole

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Roy C Orlando, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2010
• First Posted: June 23, 2010
• Study Start: June 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: December 19, 2016

Record last verified: 2016-12

Locations

US (1)