Famotidine + Antacids for Indigestion

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Stony Brook University

Must not be taking: Proton pump inhibitors

Disqualifiers: Renal insufficiency, Kidney failure, Pregnant, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken a proton pump inhibitor within 2 hours of the study treatment.

Is the combination of Famotidine and antacids like Maalox or Mylanta generally safe for humans?

Research indicates that Maalox, an antacid similar to Mylanta, is generally safe with only minor side effects like diarrhea, nausea, and constipation reported in some cases. Famotidine, known as Pepcid, is also widely used and considered safe for treating indigestion and related conditions. ^{1 2 3 4 5}

How does the drug Famotidine + Antacids for Indigestion differ from other treatments?

The combination of Famotidine with antacids like Maalox or Mylanta offers a unique approach by combining a histamine-2 blocker (Famotidine) that reduces stomach acid production with antacids that neutralize existing acid, providing both immediate and longer-lasting relief from indigestion. This dual action can be more effective than using either component alone, as it addresses both acid production and neutralization. ^{1 2 3 5 6}

Research Team

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

I have been diagnosed with indigestion.

I have severe upper abdominal pain.

Exclusion Criteria

Hypersensitivity to an ingredient in Maalox/ Mylanta or Famotidine

I have kidney failure.

I have moderate to severe problems with my kidney function.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either 20 mg of intravenous famotidine or 30 ml of oral Maalox/Mylanta, with pain assessed at 0, 15, 30, 45, and 60 minutes

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of need for rescue medications and patient satisfaction

1 hour

Treatment Details

Interventions

• Famotidine (H2 Receptor Antagonist)
• Maalox/ Mylanta (Antacid)

Trial Overview 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.

Participant Groups

Group I: Intravenous Famotidine Active Control 1 Intervention

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

Group II: Oral Maalox Active Control 1 Intervention

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

Famotidine is already approved in Canada, Japan for the following indications:

Approved in Canada as Pepcid for:

• Gastroesophageal reflux disease (GERD)
• Zollinger-Ellison syndrome
• Peptic ulcer disease

Approved in Japan as Famotidine for:

• Gastroesophageal reflux disease (GERD)
• Zollinger-Ellison syndrome
• Peptic ulcer disease

Who Is Running the Clinical Trial?

Stony Brook University

Lead Sponsor

Trials

225

Recruited

41,700+

Dr. James A. Hayward

Stony Brook University

Chief Executive Officer since 1990

PhD in Molecular Biology from the State University of New York at Stony Brook

Dr. Louis A. Peña

Stony Brook University

Chief Medical Officer since 2023

MD from Harvard Medical School

Findings from Research

In a study involving healthy human volunteers, almagate (1 g) was found to be significantly more effective than aluminium hydroxide in reducing gastric acidity, achieving an 87.5% reduction compared to 45.1% for aluminium hydroxide.

Almagate not only neutralized stomach acid more effectively but also had a longer-lasting effect, providing relief for 90 minutes compared to just 30 minutes for aluminium hydroxide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the antacid properties of almagate and aluminium hydroxide against pentagastrin-induced gastric secretion in healthy volunteers. Balanzó, J., Guarner, C., Vilardell, F.[2018]

Co-magaldrox (Maalox) significantly inhibits the adhesion of Helicobacter pylori to human gastric epithelial cells, which is crucial for its role in causing gastritis and peptic ulcers.

The treatment also reduces the secretion of interleukin-8 (IL-8) and the expression of the virulence factor heat-shock protein 60 (HSP60) on H. pylori, indicating its potential as a potent anti-H. pylori and cytoprotective agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of an aluminum hydroxide-magnesium hydroxide combination drug on adhesion, IL-8 inducibility, and expression of HSP60 by Helicobacter pylori. Kamiya, S., Yamaguchi, H., Osaki, T., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Antacid maintenance therapy in the prevention of duodenal ulcer relapse. [2019]

2. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[A comparative evaluation of the antacid properties of the preparations Maalox and Almagel]. [2015]

3. Germany pubmed.ncbi.nlm.nih.gov

Comparison of the antacid properties of almagate and aluminium hydroxide against pentagastrin-induced gastric secretion in healthy volunteers. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

Treatment of gastric pyrosis with almagate in patients with and without endoscopically demonstrable duodenal ulcer. A multicentre clinical trial. [2014]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Intragastric pH in the gastroprotective and ulcer-healing activity of aluminum-containing antacids. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Effect of an aluminum hydroxide-magnesium hydroxide combination drug on adhesion, IL-8 inducibility, and expression of HSP60 by Helicobacter pylori. [2019]