Famotidine and Antacids for Treatment of Dyspepsia

Last updated: April 28, 2025
Sponsor: Stony Brook University
Overall Status: Active - Recruiting

Phase

4

Condition

Esophageal Disorders

Non-ulcer Dyspepsia (Nud)

Heartburn (Pediatric)

Treatment

Oral Maalox/ Mylanta

Intravenous Famotidine

Clinical Study ID

NCT06241183
IRB2023-00188
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject Age ≥ 18 years of age

  2. Patient diagnosed with dyspepsia

  3. Present at the ED with upper abdominal pain score of at least 3

Exclusion

Exclusion Criteria:

  1. Hypersensitivity to an ingredient in Maalox/ Mylanta or Famotidine

  2. Moderate to Severe Renal Insufficiency (precaution)

  3. Kidney Failure

  4. Pregnant or Nursing

  5. Verbal pain score less than 3

  6. Inability to tolerate oral medications

  7. Bowel Obstruction

  8. Proton pump inhibitor within 2 hours of study treatment

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Oral Maalox/ Mylanta
Phase: 4
Study Start date:
November 09, 2023
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Stony Brook University Hospital

    Stony Brook, New York 11794
    United States

    Active - Recruiting

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