Famotidine and Antacids for Treatment of Dyspepsia

GERD Clinical Trial

Official title:

Comparing Intravenous Famotidine and Oral Antacids in the Treatment of Dyspepsia in the Emergency Department

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06241183
• Other study ID #: IRB2023-00188
• Status: Recruiting
• Phase: Phase 4
• Start date: November 9, 2023
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Stony Brook University
• Contact: Adam Singer, MD
• Phone: 6314447857
• Email: adam.singer[@]stonybrookmedicine.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acid Reflux
• Dyspepsia
• Gastroesophageal Reflux
• GERD

Intervention

Drug:
• Intravenous Famotidine
Patients in this group will receive 20mg IV Famotidine.
• Oral Maalox/ Mylanta
Patients in this group will receive 30 ml Maalox/ Mylanta.

Locations

Country	Name	City	State
United States	Stony Brook University Hospital	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Verbal Numerical Pain Score	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.	at 1 hour
Secondary	Need for Rescue Medications	Investigators will assess frequency of need for rescue medications between groups.	at 1 hour
Secondary	Satisfaction with Assigned Medication	Investigators will gather data regarding patient satisfaction with their assigned treatment using a 5 item likert scale from very dissatisfied to very satisfied	at 1 hour