Do Acid Sensing Ion Channels Contribute to Heartburn?

NCT01095133 | Completed Phase 1

• 1 other identifier: 09-0289
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastroesophageal Reflux Disease; Heartburn

Keywords

Gastroesophageal reflux disease; Heartburn

Outcome Measures

Primary Outcomes (1)

• Bernstein test to measure Initial Onset of Heartburn Symptoms

  Subjects have esophageal perfusion with active agent or placebo followed by esophageal perfusion with HCl until heartburn occurs or 15 min is reached without heartburn. Time to onset of heartburn is compared for each arm of the study. There is no months or years issue here. It is an acute study with a time frame of minutes to heartburn during acid perfusion. The study begins and ends with the acid perfusion test, there is durable treatment other than two five minute perfusions of the esophagus with placebo or active drug.

  15 minutes after start of Bernstein test

Secondary Outcomes (1)

• Bernstein test to measure onset of Heartburn Symptoms after receipt of medication or placebo

  35 Minutes after start of first Bernstein test

Study Arms (2)

Amiloride

EXPERIMENTAL

Drug: Amiloride

Placebo

PLACEBO COMPARATOR

Drug: Amiloride; Drug: Placebo

Interventions

Amiloride DRUG

dosage form: intraesophageal amiloride infusion dosage: liquid 1 mM amiloride concentration duration: 5 minute infusion given once frequency: 1 time

Also known as: Midamor

Amiloride; Placebo

Placebo DRUG

dosage form: intraesophageal saline infusion dosage: normal Saline (0.91% w/v of NaCl) duration: 5 minutes given once frequency: 1 time

Placebo

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

The Clinical and Translational Research Center

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Heartburn

Interventions

Amiloride

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Roy Orlando, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: March 5, 2010
• First Posted: March 30, 2010
• Study Start: March 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 20, 2012

Record last verified: 2012-09

Locations

US (1)