Do Acid Sensing Ion Channels Contribute to Heartburn?

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to learn about whether treating the esophagus with amiloride reduces either the frequency or the time to onset of acid-induced heartburn in patients with nonerosive reflux disease. In particular, we are looking at people who have either had complete relief while using a Proton Pump Inhibitor (PPI) or who have only had some relief of symptoms while on a PPI.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Treatments: Amiloride

Criteria

Inclusion Criteria:

• Adults, 18-59 years old

• moderate heartburn at least 3 days/week

• males and non-pregnant/non-lactating females

• Complete relief while using a PPI or only some relief of symptoms while on a PPI

Exclusion Criteria:

• erosive esophagitis

• unable or unwilling to undergo endoscopy and biopsy or Bernstein testing

• eosinophilic esophagitis

• negative Bernstein test

• known hypersensitivity to amiloride

• renal disease

• diabetes

• hypotension

• electrolyte imbalance

• contraindication to diuretics, including taking lithium or ACE inhibitors. -history of gastric or esophageal surgery

• history of ZE syndrome

• bleeding disorder

• UGI bleeding

• esophageal motor disorder

• esophageal stricture

• Barrett's esophagus

• UGI malignancy

• esophageal varices

• subjects with current malabsorption

• inflammatory bowel disease

• severe heart-lung-liver-renal-cerebrovascular disease

• subjects post-transplant

• diabetes

• actively taking the following medications: tricyclic antidepressants, quinidine, quinine, dilantin, warfarin, narcotic analgesics, antineoplastic agents, salicylates (except a baby aspirin for cardiovascular protection); steroids, NSAIDs (including COX-2 inhibitors), KCl, anti-tuberculosis medication, bisphosphonates, and triamterene, cyclosporine, tacrolimus, and other potassium sparing drugs like spironolactone

• serum potassium of 5.5 mEq/L or higher