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Famotidine and Antacids for Treatment of Dyspepsia

ConditionsDyspepsiaGERDAcid Reflux
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorStony Brook University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject Age ≥ 18 years of age

Patient diagnosed with dyspepsia

Present at the ED with upper abdominal pain score of at least 3

Disqualifiers

Hypersensitivity to an ingredient in Maalox/ Mylanta or Famotidine

Moderate to Severe Renal Insufficiency (precaution)

Kidney Failure

Pregnant or Nursing

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intravenous Famotidine

    Drug

    Patients in this group will receive 20mg IV Famotidine.

  • Oral Maalox/ Mylanta

    Drug

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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Intravenous FamotidineActive comparator 1 intervention
Group B: Oral MaaloxActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
at 1 hour

Secondary outcomes

1

Need for Rescue Medications

Investigators will assess frequency of need for rescue medications between groups.

Time frame
at 1 hour
2

Satisfaction with Assigned Medication

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.

Time frame
at 1 hour

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stony Brook University

Lead sponsor

Source ClinicalTrials.gov
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