Do Acid Sensing Ion Channels Contribute to Heartburn? (NCT01095133) | Clinical Trial Compass
CompletedPhase 1
Do Acid Sensing Ion Channels Contribute to Heartburn?
United States24 participantsStarted 2010-03
Plain-language 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.
Who can participate
Age range18 Years – 59 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Bernstein test to measure Initial Onset of Heartburn Symptoms
Timeframe: 15 minutes after start of Bernstein test