Dexilant Treatment in Gastrointestinal Reflux Disease (GERD Related Non Cardiac Chest Pain
Withdrawn before enrolling · Phase 4 · Has a placebo group
Conditions studied: Chest Pain, Gastrointestinal Reflux Disease
In brief
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.
Key facts
- Study ID
- NCT01637571
- Run by
- University of Iowa
- People needed
- 0
- Last updated by the study team
- 2012-07-11
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
Full record on ClinicalTrials.gov
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