Chest Pain, Gastrointestinal Reflux Disease
Conditions
Keywords
GERD, NCCP, chest pain, reflux, GERD related non-cardiac chest pain
Brief summary
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.
Interventions
DRUGDexilant
60mg of Dexilant QD for 12 weeks
DRUGDexilant Placebo
60mg of Dexilant placebo QD for 12 weeks
Sponsors
University of Iowa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of chest pain episodes in treatment vs placebo groups | 12 weeks | the number of chest pain episodes during the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of chest pain episodes | 12 weeks | how strong the chest pain episodes are |
| Sensory thresholds for first sensation | 12 weeks | the balloon distension level when a sensation is first felt |
| Sensory thresholds for discomfort | 12 weeks | the balloon distension level when discomfort is felt |
| Sensory thresholds for pain | 12 weeks | the balloon distension level when pain is felt |
| duration of chest pain episodes | 12 weeks | how long the chest pain episodes last |
Countries
United States
Outcome results
None listed