NCT06241183

Famotidine and Antacids for Treatment of Dyspepsia

Comparing Intravenous Famotidine and Oral Antacids in the Treatment of Dyspepsia in the Emergency Department

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Stony Brook University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will be conducted in the Emergency Department at Stony Brook University Hospital. Investigators intend to enroll approximately 80 patients who present to the emergency department with dyspepsia symptoms. The patients will be randomized to one of two groups: one group will receive 20 mg of intravenous famotidine and the other will receive 30 ml of oral Maalox/ Mylanta. The verbal numeric pain score (VNP) will be used to measure pain at 0 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes after administration of the study drug. Pain severity assessments will be performed by an investigator blinded to study treatment. Data will also be collected regarding demographic, clinical information, patient satisfaction and the need for rescue medications in each of the two study groups at the end of the 60-minute study period. At the end of the study period, the patients may be treated with additional analgesia at the discretion of their ED provider.

Conditions

• Dyspepsia
• GERD
• Acid Reflux

Interventions

Type	Name	Description
DRUG	Intravenous Famotidine	Patients in this group will receive 20mg IV Famotidine.
DRUG	Oral Maalox/ Mylanta	Patients in this group will receive 30 ml Maalox/ Mylanta.

Timeline

• Start date: 2023-11-09
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-02-05
• Last updated: 2025-05-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study