Recruiting

Famotidine & Antacids

Sponsor:

Stony Brook University

Code:

NCT06241183

Conditions

Dyspepsia

GERD

Acid Reflux

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intravenous Famotidine

Oral Maalox/ Mylanta

Study Details

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

Study ID

NCT06241183

Start date

Nov 9, 2023

Status verified date

Jun, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Intravenous Famotidine

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

active comparator: Oral Maalox

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

Interventions

Intravenous Famotidine

Patients in this group will receive 20mg IV Famotidine.

Oral Maalox/ Mylanta

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

Primary outcome measure

  • Verbal Numerical Pain Score [ Time Frame: at 1 hour ]

Central Contacts and Locations

Central contacts

Adam Singer, MD

6314447857adam.singer@stonybrookmedicine.edu

Locations

Stony Brook University Hospital

Recruiting

Stony Brook, New York, United States, 11794

Principal Investigator:

Adam Singer, MD

More Information

Sponsor

Stony Brook University

Last update posted

Jun 2, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2026-06-02.