Famotidine and Antacids for Treatment of Dyspepsia

NCT06241183 | Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB2023-00188
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare intravenous famotidine, an H2 receptor antagonist, and Maalox/ Mylanta, an oral antacid, in treatment of dyspepsia in the emergency department. The goal of this study is to reduce patients' pain based on the verbal numerical pain scale. The anticipated outcome is for pain levels in both groups to decrease. It is expected that antacids will improve symptoms more quickly and to a greater degree within an hour of taking medication based on the results of similar studies.

Conditions

Dyspepsia; GERD; Acid Reflux

Keywords

dyspepsia; GERD; Acid Reflux; H2 receptor antagonist; antacid; Maalox; Mylanta; Famotidine

Outcome Measures

Primary Outcomes (1)

• Verbal Numerical Pain Score

  Patients will be asked to rate their pain on a scale of 0 to 10 with 0 indicating no pain and 10 indicating the worst pain imaginable every 15 minutes for 60 minutes.

  at 1 hour

Secondary Outcomes (2)

• Need for Rescue Medications

  at 1 hour

• Satisfaction with Assigned Medication

  at 1 hour

Study Arms (2)

Intravenous Famotidine

ACTIVE COMPARATOR

Patients in this group will receive 20 mg of intravenous famotidine.

Drug: Intravenous Famotidine

Oral Maalox

ACTIVE COMPARATOR

Patients in the group will receive 30 ml of oral Maalox/ Mylanta.

Drug: Oral Maalox/ Mylanta

Interventions

Intravenous Famotidine DRUG

Patients in this group will receive 20mg IV Famotidine.

Also known as: H2 Receptor Antagonist

Intravenous Famotidine

Oral Maalox/ Mylanta DRUG

Patients in this group will receive 30 ml Maalox/ Mylanta.

Also known as: Antacid

Oral Maalox

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject Age ≥ 18 years of age
• Patient diagnosed with dyspepsia
• Present at the ED with upper abdominal pain score of at least 3

You may not qualify if:

• Hypersensitivity to an ingredient in Maalox/ Mylanta or Famotidine
• Moderate to Severe Renal Insufficiency (precaution)
• Kidney Failure
• Pregnant or Nursing
• Verbal pain score less than 3
• Inability to tolerate oral medications
• Bowel Obstruction
• Proton pump inhibitor within 2 hours of study treatment

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

RECRUITING

MeSH Terms

Conditions

Dyspepsia; Gastroesophageal Reflux

Interventions

Histamine H2 Antagonists; aluminum hydroxide, magnesium hydroxide, drug combination; aluminum hydroxide, magnesium hydroxide, simethicone drug combination; Antacids

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Gastrointestinal Agents; Therapeutic Uses

Central Study Contacts

Adam Singer, MD

CONTACT

6314447857; adam.singer@stonybrookmedicine.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research team member assessing verbal pain score will be blinded to the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Interim Chair of the Department of Emergency Medicine

Model Details: Subjects are divided into two groups and randomly assigned to receive either study drug.

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: February 5, 2024
• Study Start: November 9, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)