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H2 Receptor Antagonist
Famotidine + Antacids for Indigestion
Phase 4
Recruiting
Research Sponsored by Stony Brook University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject Age ≥ 18 years of age
Patient diagnosed with dyspepsia
Must not have
Kidney Failure
Inability to tolerate oral medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 hour
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial aims to compare the effectiveness of intravenous famotidine (an H2 receptor antagonist) and Maalox/Mylanta (an oral antacid) in treating dyspepsia in
Who is the study for?
This trial is for adults over 18 with dyspepsia, experiencing upper abdominal pain of at least a moderate level. It's not suitable for those with severe kidney issues, pregnant or nursing women, people who can't take oral meds, have bowel obstruction, recently took proton pump inhibitors, or are allergic to the study medications.
What is being tested?
The study compares intravenous Famotidine and oral Maalox/ Mylanta in treating indigestion in emergency department patients. The goal is to see which medication reduces pain more effectively within an hour based on patient-reported pain levels.
What are the potential side effects?
Possible side effects include headaches, constipation or diarrhea from Famotidine; and chalky taste, stomach cramps or nausea from Maalox/ Mylanta. Reactions vary by individual.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have been diagnosed with indigestion.
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I have severe upper abdominal pain.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have kidney failure.
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I cannot take medications by mouth.
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I have a blockage in my intestines.
Select...
I take a proton pump inhibitor less than 2 hours before my study treatment.
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My pain level is usually below 3 on a scale of 0-10.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 hour
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 hour
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Verbal Numerical Pain Score
Secondary study objectives
Need for Rescue Medications
Satisfaction with Assigned Medication
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Group I: Intravenous FamotidineActive Control1 Intervention
Patients in this group will receive 20 mg of intravenous famotidine.
Group II: Oral MaaloxActive Control1 Intervention
Patients in the group will receive 30 ml of oral Maalox/ Mylanta.
Find a Location
Who is running the clinical trial?
Stony Brook UniversityLead Sponsor
223 Previous Clinical Trials
41,472 Total Patients Enrolled