Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-25 @ 3:02 AM
NCT ID:
NCT01095133
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
59 Years
Study:
NCT01095133
Study Brief:
Protocol Section:
NCT01095133