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

University of Iowa

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Chest Pain Gastrointestinal Reflux Disease

Interventions

DexilantDRUG

60mg of Dexilant QD for 12 weeks

Dexilant PlaceboDRUG

60mg of Dexilant placebo QD for 12 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Outcomes

Primary Outcomes

Frequency of chest pain episodes in treatment vs placebo groups

the number of chest pain episodes during the study

Time frame: 12 weeks

Secondary Outcomes

Intensity of chest pain episodes

how strong the chest pain episodes are

Time frame: 12 weeks

Sensory thresholds for first sensation

the balloon distension level when a sensation is first felt

Time frame: 12 weeks

Sensory thresholds for discomfort

the balloon distension level when discomfort is felt

Time frame: 12 weeks

Sensory thresholds for pain

the balloon distension level when pain is felt

Time frame: 12 weeks

duration of chest pain episodes

how long the chest pain episodes last

Time frame: 12 weeks

Data from ClinicalTrials.gov

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