Famotidine and Antacids for Treatment of Dyspepsia

Phase 4

Recruiting

• Conditions: Acid Reflux; Dyspepsia; GERD
• Interventions: Drug: Oral Maalox/ Mylanta; Drug: Intravenous Famotidine

• Registration Number: NCT06241183
• Lead Sponsor: Stony Brook University

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.

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.

Study Timeline

• Study Start: 2023-11-09
• Study First Submitted: 2024-01-16
• Study First Submitted QC: 2024-01-26
• Study First Posted: 2024-02-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Maalox	Oral Maalox/ Mylanta	Patients in the group will receive 30 ml of oral Maalox/ Mylanta.
Intravenous Famotidine	Intravenous Famotidine	Patients in this group will receive 20 mg of intravenous famotidine.

Primary Outcome Measures

Name	Time	Method
Verbal Numerical Pain Score	at 1 hour	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.

Secondary Outcome Measures

Name	Time	Method
Need for Rescue Medications	at 1 hour	Investigators will assess frequency of need for rescue medications between groups.
Satisfaction with Assigned Medication	at 1 hour	Investigators will gather data regarding patient satisfaction with their assigned treatment using a 5 item likert scale from very dissatisfied (1), dissatisfied (2) neither satisfied nor dissatisfied (3), satisfied (4) and very satisfied (5). The outcome will be measured as the percentages of patients choosing very satisfied or satisfied with their assigned medications.

Trial Locations

Locations (1)

Stony Brook University Hospital; 🇺🇸 Stony Brook, New York, United States