Do Acid Sensing Ion Channels Contribute to Heartburn?

Completed · Phase 1 · Has a placebo group

Conditions studied: Gastroesophageal Reflux Disease, Heartburn

In brief

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.

Key facts

Study ID

NCT01095133

Run by

University of North Carolina, Chapel Hill

People needed

24

Starts

2010-03-01

Expected to finish

2011-09-01

Last updated by the study team

2012-09-20

Who can join

Age: 18 and older, up to 59. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Clinical and Translational Research Center — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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