Famotidine and Antacids for Treatment of Dyspepsia

NCT ID: NCT06241183

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-09
• Study Completion Date: 2025-12-31

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.

Conditions

Dyspepsia; GERD; Acid Reflux

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intravenous Famotidine

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

Group Type: ACTIVE_COMPARATOR

Intravenous Famotidine

Intervention Type: DRUG

Patients in this group will receive 20mg IV Famotidine.

Oral Maalox

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

Group Type: ACTIVE_COMPARATOR

Oral Maalox/ Mylanta

Intervention Type: DRUG

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

Interventions

Intravenous Famotidine

Patients in this group will receive 20mg IV Famotidine.

Intervention Type: DRUG

Oral Maalox/ Mylanta

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

Intervention Type: DRUG

Other Intervention Names

H2 Receptor Antagonist; Antacid

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Adam Singer

Professor and Interim Chair of the Department of Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stony Brook University Hospital

Stony Brook, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Adam Singer, MD

Role: CONTACT

adam.singer@stonybrookmedicine.edu

6314447857

Facility Contacts

Andrea Gowie

Role: primary

Other Identifiers

IRB2023-00188

Identifier Type: -

Identifier Source: org_study_id