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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chest Pain, Gastrointestinal Reflux Disease

Intervention / Treatment
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* Drug: Dexilant
* Drug: Dexilant Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-75 years NERD, or GERD LA Class A-B (endoscopy) Subjects with positive pH testing At least one episode of chest pain a week in the past month Previous negative cardiac evaluation (EKG ± stress test ± coronary angiogram) Negative esophageal evaluation for a motility disorder (Nutcracker esophagus, achalasia) Exclusion Criteria: Subjects requiring narcotics or other pain medications, Subjects with known LA class C-D, Barrett's esophagus or peptic stricture on endoscopy Subjects with previous upper gastrointestinal surgery Pregnancy Subjects with diabetes, neuromuscular disorders, or other severe co-morbidities (Cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, neurologic, and psychiatric). Subjects with upper airway symptoms (such as hoarseness, wheezing, laryngospasm). Medications such as baclofen, and prokinetic agents. History of substance abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexilant<br>60mg of Dexilant QD for 12 weeks | Drug: Dexilant<br>* 60mg of Dexilant QD for 12 weeks<br>|
| Placebo Comparator: Placebo<br>60mg of Dexilant placebo QD for 12 weeks | Drug: Dexilant Placebo<br>* 60mg of Dexilant placebo QD for 12 weeks<br>* Other names: Dexlansoprazole;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD, NCCP, chest pain, reflux, GERD related non-cardiac chest pain