Famotidine and Antacids for Treatment of Dyspepsia

Stony Brook University

Status and phase: Enrolling; Phase 4

Conditions: Dyspepsia; Acid Reflux; GERD

Treatments: Drug: Oral Maalox/ Mylanta; Drug: Intravenous Famotidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06241183

IRB2023-00188

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Intravenous Famotidine

Active Comparator group

Description:

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

Treatment:

Drug: Intravenous Famotidine

Oral Maalox

Active Comparator group

Description:

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

Treatment:

Drug: Oral Maalox/ Mylanta