Famotidine + Antacids for Indigestion

Overseen By Adam Singer, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Stony Brook University

Must not be taking: Proton pump inhibitors

Disqualifiers: Renal insufficiency, Kidney failure, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 hour

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments for indigestion, also known as dyspepsia, in the emergency room setting. The aim is to determine whether intravenous famotidine (a type of heartburn medication) or oral antacids like Maalox or Mylanta reduce stomach pain more quickly. Participants will be divided into two groups to compare the speed and effectiveness of the treatments. The trial seeks individuals diagnosed with dyspepsia who are experiencing significant upper abdominal pain. As a Phase 4 trial, the treatments are already FDA-approved and proven effective, aiming to understand how they benefit more patients.

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.

What is the safety track record for these treatments?

Research has shown that famotidine, known by brand names like Pepcid, has been safely used for years to treat heartburn and stomach ulcers. It is available both by prescription and over-the-counter. Most people tolerate it well, but like any medicine, it can cause side effects. Common side effects include headaches and dizziness, though these are infrequent.

Maalox, an antacid, is also well-known for relieving upset stomach and heartburn. It is usually safe, but some people might experience mild side effects like diarrhea or constipation.

Both treatments in the trial have a history of being well-tolerated, suggesting they are generally safe for their intended uses. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the treatments of famotidine and antacids for indigestion because they offer distinct approaches compared to standard options like proton pump inhibitors (PPIs) and H2 blockers. Famotidine, when administered intravenously, provides rapid relief by blocking histamine receptors in the stomach to reduce acid production, which could be particularly beneficial for severe cases needing quick intervention. On the other hand, oral Maalox or Mylanta provides a soothing effect by neutralizing stomach acid on contact, offering immediate symptom relief. This combination could potentially provide a more comprehensive and faster-acting solution for indigestion than traditional oral medications.

What evidence suggests that this trial's treatments could be effective for dyspepsia?

Research has shown that famotidine, which participants in this trial may receive, effectively reduces stomach acid and relieves indigestion symptoms. It lessens the need for extra antacids and can treat heartburn and acid reflux. Meanwhile, Maalox, another treatment option in this trial, is a liquid antacid that quickly lowers stomach acid and eases discomfort in the stomach and esophagus. A review found Maalox to be very effective in relieving heartburn and other indigestion symptoms. Both treatments have proven effective in reducing pain and discomfort associated with indigestion. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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 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 cannot take medications by mouth.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Famotidine
• Maalox/ Mylanta

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.

How Is the Trial Designed?

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 United States, European Union, Canada, Japan for the following indications:

Approved in United States as Pepcid for:

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

Approved in European Union as Famotidine for:

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

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+

Published Research Related to This Trial

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]

In a trial involving 169 patients with gastric pyrosis, the new antacid Almax (almagate) was found to be highly effective, with most patients symptom-free after two weeks, regardless of whether they had an active duodenal ulcer or not.

Patients taking Almax alone required higher doses compared to those receiving it alongside antisecretory drugs, but overall tolerance was excellent, with minimal side effects reported, and 84.2% of patients preferred Almax over their previous antacid treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of gastric pyrosis with almagate in patients with and without endoscopically demonstrable duodenal ulcer. A multicentre clinical trial. Suau, A., Dominguez Martin, A., Ferrando Cucarella, J., et al.[2014]

Acidified forms of Maalox 70 and Al(OH)3 were found to be significantly more effective than unmodified versions in protecting against acute gastric mucosal lesions in rats, likely due to a mild irritant effect that promotes mucosal healing.

The ulcer-healing properties of these aluminum-containing antacids do not depend on gastric acid secretion or the production of prostaglandins, suggesting that their healing mechanism operates independently of these factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intragastric pH in the gastroprotective and ulcer-healing activity of aluminum-containing antacids. Konturek, SJ., Brzozowski, T., Garlicki, J., et al.[2018]

In a study involving 24 duodenal ulcer patients, Maalox demonstrated superior antacid properties compared to Almagel, particularly in terms of pH response and alkalification in the stomach.

Maalox was effective in treating various gastrointestinal conditions, with 25 patients responding positively for duodenal ulcers and showing high safety and minimal side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A comparative evaluation of the antacid properties of the preparations Maalox and Almagel]. Grebenev, AL., Sheptulin, AA., Okhlobystin, AV.[2015]

In a study of 251 patients with healed duodenal ulcers, Maalox TC taken twice daily (bd) was found to be as effective as cimetidine in preventing ulcer relapse, with a relapse rate of 23% for Maalox bd and 25% for cimetidine, both significantly better than the 57% relapse rate in the placebo group.

Both Maalox TC and cimetidine were well-tolerated, with adverse events occurring in about half of the patients across all treatment groups, but no significant changes in serum magnesium levels, indicating a favorable safety profile for these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antacid maintenance therapy in the prevention of duodenal ulcer relapse. Bardhan, KD., Hunter, JO., Miller, JP., et al.[2019]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK534778/

Famotidine - StatPearls - NCBI Bookshelf - NIH Famotidine reduces gastric acid secretion in individuals, and its pharmacological properties are utilized in treating gastrointestinal conditions related to ...

2. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2003/020325_S015_PEPCID%20AC%20TABLETS_BIOPHARMR.pdf

clinical review - accessdata.fda.gov Patients in the famotidine 20mg group, compared to the 10 mg group did not show consistent significant statistical difference with regard to the ...

3. mayoclinic.org mayoclinic.org/drugs-supplements/famotidine-oral-route/description/drg-20072972

Famotidine (oral route) - Side effects & dosage Famotidine is used to treat stomach ulcers (gastric and duodenal), erosive esophagitis (heartburn or acid indigestion), and gastroesophageal reflux disease ( ...

4. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/615797

Famotidine Relieves Symptoms of Gastroesophageal ... Antacid consumption was significantly reduced in the group given famotidine 20 mg BID as compared with placebo. Both famotidine regimens resulted in a ...

5. nejm.org nejm.org/doi/full/10.1056/NEJM199605303342204

Famotidine for the Prevention of Gastric and Duodenal ... Treatment with high-dose famotidine significantly reduces the cumulative incidence of both gastric and duodenal ulcers in patients with arthritis receiving ...

6. pepcid.com pepcid.com/our-products/maximum-strength-pepcid-ac

Maximum Strength PEPCID AC® Tablets with Famotidine The PEPCID® brand: Has provided safe & effective heartburn relief for 35 years when used as directed. Delivers clinically proven, heartburn relief you can trust.

7. webmd.com webmd.com/drugs/2/drug-5035-2033/famotidine-oral/famotidine-oral/details

Famotidine (Pepcid, Zantac 360) – Uses, Side Effects, and ... Famotidine is used to treat heartburn, ulcers, and other conditions caused by too much stomach acid. It is available by prescription and over-the-counter (OTC).

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2018/019462s039lbl.pdf

pepcid® tablets - accessdata.fda.gov Trials have not assessed the safety of PEPCID in uncomplicated active DU for periods of more than 8 weeks. ... PEPCID-treated patients experienced complete relief ...