Dexilant Treatment in Gastrointestinal Reflux Disease (GERD Related Non Cardiac Chest Pain (Dexilant)

The Effect of Dexilant Treatment on Esophageal Hypersensitivity in GERD Related Non Cardiac Chest Pain Patients

The purpose of this study is to investigate a new treatment for non-cardiac chest pain (NCCP) related to gastrointestinal reflux disease (GERD), called Dexilant. The investigators would like to test its effectiveness in treating NCCP.

The patient will undergo esophageal balloon distention testing (EBDT) before and after taking the new treatment for one month (Dexilant). EBDT evaluates the sensation and mechanical properties of the esophagus. A catheter with a deflated balloon is placed through the mouth and into the esophagus and the balloon is inflated with water. ECG and labs will be done throughout the study as a measurement of safety.

Study Overview

• Status: Withdrawn
• Conditions: Chest Pain; Gastrointestinal Reflux Disease
• Intervention / Treatment: Drug: Dexilant; Drug: Dexilant Placebo

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Aged 18-75 years
2. NERD, or GERD LA Class A-B (endoscopy)
3. Subjects with positive pH testing
4. At least one episode of chest pain a week in the past month
5. Previous negative cardiac evaluation (EKG ± stress test ± coronary angiogram)
6. Negative esophageal evaluation for a motility disorder (Nutcracker esophagus, achalasia)

Exclusion Criteria:

1. Subjects requiring narcotics or other pain medications, Subjects with known LA class C-D, Barrett's esophagus or peptic stricture on endoscopy
2. Subjects with previous upper gastrointestinal surgery
3. Pregnancy
4. Subjects with diabetes, neuromuscular disorders, or other severe co-morbidities
5. (Cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, neurologic, and psychiatric).
6. Subjects with upper airway symptoms (such as hoarseness, wheezing, laryngospasm).
7. Medications such as baclofen, and prokinetic agents.
8. History of substance abuse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexilant; 60mg of Dexilant QD for 12 weeks	Drug: Dexilant; 60mg of Dexilant QD for 12 weeks
Placebo Comparator: Placebo; 60mg of Dexilant placebo QD for 12 weeks	Drug: Dexilant Placebo; 60mg of Dexilant placebo QD for 12 weeks; Other Names: Dexlansoprazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of chest pain episodes in treatment vs placebo groups	the number of chest pain episodes during the study	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of chest pain episodes	how strong the chest pain episodes are	12 weeks
Sensory thresholds for first sensation	the balloon distension level when a sensation is first felt	12 weeks
Sensory thresholds for discomfort	the balloon distension level when discomfort is felt	12 weeks
Sensory thresholds for pain	the balloon distension level when pain is felt	12 weeks
duration of chest pain episodes	how long the chest pain episodes last	12 weeks

Collaborators and Investigators

• Sponsor: University of Iowa
• Investigators: Principal Investigator: Ron Schey, MD, University of Iowa

Study record dates

Study Major Dates

• Study Start: December 6, 2022
• Primary Completion: December 6, 2022
• Study Completion: December 6, 2022

Study Registration Dates

• First Submitted: December 6, 2011
• First Submitted That Met QC Criteria: July 10, 2012
• First Posted (Estimate): July 11, 2012

Study Record Updates

• Last Update Posted (Estimate): July 11, 2012
• Last Update Submitted That Met QC Criteria: July 10, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: GERD; NCCP; chest pain; reflux; GERD related non-cardiac chest pain
• Additional Relevant MeSH Terms: Digestive System Diseases; Pain; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophagitis; Peptic Ulcer; Duodenal Diseases; Gastroesophageal Reflux; Esophagitis, Peptic; Chest Pain; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole
• Other Study ID Numbers: 201102718

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No