Clinical trial NCT06241183: Famotidine and Antacids for Treatment of Dyspepsia
Official title: Comparing Intravenous Famotidine and Oral Antacids in the Treatment of Dyspepsia in the Emergency Department
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Dyspepsia
GERD
Acid Reflux
Keywords: dyspepsia
GERD
Acid Reflux
H2 receptor antagonist
antacid
Maalox
Mylanta
Famotidine
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects are divided into two groups and randomly assigned to receive either study drug.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Verbal Numerical Pain Score
timeFrame: at 1 hour
Secondary outcomes:
measure: Need for Rescue Medications
timeFrame: at 1 hour
measure: Satisfaction with Assigned Medication
timeFrame: at 1 hour
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
Study officials:
References: