Omeprazole for Ulcers

(OPEN-IT Trial)

Overseen By Stephen Firkins, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: Stephen Firkins

Must be taking: Proton-pump inhibitors

Disqualifiers: Refusal PPI, Current open-capsule PPI

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 3 to 12 months

122 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the best method for taking acid-blocking medications, specifically omeprazole, to treat stomach ulcers in individuals who have undergone gastric bypass surgery. It seeks to determine if taking the medication by opening the capsule and consuming only the contents is more effective than swallowing the whole capsule. Participants must undergo an upper endoscopy every three months to monitor ulcer healing. The trial seeks individuals diagnosed with ulcers after gastric bypass surgery. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits 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 will need to start taking a specific acid-blocking medication (proton-pump inhibitor) as part of the study.

What is the safety track record for omeprazole?

Research has shown that omeprazole is generally safe and well-tolerated. Studies involving over 3,000 patients found it effective for treating stomach and duodenal ulcers, as well as gastroesophageal reflux disease (GERD). Most people do not experience serious side effects, though some may have mild issues like headaches, stomach pain, or nausea, which usually resolve on their own.

The FDA has approved omeprazole, and its widespread use over the years supports its safety. In this trial, participants will take omeprazole either by swallowing the whole capsule or by opening it and taking just the contents. Both methods use the same safe medication, just in different forms. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for ulcers, like other proton pump inhibitors (PPIs), work by reducing stomach acid to allow healing. However, researchers are excited about the Omeprazole trial because it explores two unique ways of administering the same drug. The "Intact-capsule" method is the standard form, but the "Open-capsule" approach could offer an alternative for patients who have trouble swallowing pills. This could potentially increase patient compliance and improve overall treatment effectiveness, making it an exciting development in ulcer care.

What is the effectiveness track record for omeprazole in treating stomach ulcers?

Research has shown that omeprazole effectively treats stomach ulcers. Studies have found that it heals ulcers and relieves pain better than other treatments. One study showed that omeprazole healed ulcers in 97.5% of patients within four weeks. This medicine reduces stomach acid, which helps ulcers heal faster. In this trial, participants will receive omeprazole either as an intact capsule or an open capsule. Patients have experienced improvements in symptoms and ulcer healing with omeprazole, making it a reliable choice for treating ulcers after gastric bypass surgery. ^{6 7 8 9 10}

Who Is on the Research Team?

Stephen Firkins, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for patients with stomach ulcers after gastric bypass surgery. They must be diagnosed with marginal ulceration via endoscopy and willing to start proton-pump inhibitor (PPI) medication. Those already using open-capsule PPIs at ulcer diagnosis or refusing to take PPIs cannot participate.

Inclusion Criteria

I have been diagnosed with ulcers after gastric bypass surgery.

Exclusion Criteria

I refuse to take PPI medication.

I am currently using open-capsule PPIs for my ulcer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive proton pump inhibitors either as an open-capsule or intact-capsule until confirmed ulcer healing

3 to 12 months

Endoscopy every 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Omeprazole

Trial Overview The study tests if taking the contents of an acid-blocking capsule (Omeprazole 40 mg) without the outer shell is more effective than swallowing it whole in treating ulcers post-gastric bypass. Participants will have their ulcer healing monitored through regular endoscopies every three months.

How Is the Trial Designed?

Group I: Open-capsule Experimental Treatment 1 Intervention

Subjects in this arm will be treated with omeprazole 40 milligrams twice daily (or alternative medication if not covered by the subject's insurance) taken as an open-capsule until confirmed ulcer healing.

Group II: Intact-capsule Active Control 1 Intervention

Subjects in this arm will be treated with omeprazole 40 milligrams twice daily (or alternative medication if not covered by the subject's insurance) taken as an intact-capsule until confirmed ulcer healing or potential cross-over.

Omeprazole is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Losec for:

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

Approved in United States as Prilosec for:

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

Approved in Canada as Omez for:

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

Approved in Japan as Omeprazole for:

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

Approved in China as Omeprazole for:

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

Approved in Switzerland as Omeprazole for:

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

Who Is Running the Clinical Trial?

Stephen Firkins

Lead Sponsor

Carlos Roberto Simons-Linares

Lead Sponsor

Trials

2

Recruited

190+

Published Research Related to This Trial

Omeprazole is an effective treatment for peptic ulcers and reflux esophagitis, demonstrating strong inhibition of gastric acid secretion.

In short-term use, omeprazole shows a safety profile comparable to other commonly used acid-related disorder medications, with minimal adverse events and only a slight increase in serum gastrin levels due to its mechanism of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of omeprazole. Adverse events with short-term treatment. Nelis, GF.[2018]

Omeprazole has been administered to over 2500 subjects, primarily in short-term studies lasting 2-4 weeks, with some patients receiving it for more than 2 years.

No specific pattern of side effects has been identified that can be directly linked to omeprazole, suggesting it may have a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety aspects of omeprazole. Sölvell, L.[2019]

In a study of 17 patients with duodenal ulcers, omeprazole (Losec) demonstrated a high healing rate, with 94% of ulcers healed after 4 weeks of treatment, significantly improving patient outcomes (P < 0.001).

Omeprazole also effectively eliminated Helicobacter pylori in 11 out of 16 patients, indicating its role in reducing chronic gastritis and improving overall gastric health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effect of omeprazole on healing of duodenal ulcers, Helicobacter pylori and gastritis]. Zelenková, J., Soucková, A., Drábek, J., et al.[2020]

The rapid onset encephalopathy and associated symptoms in two elderly men were linked to the coadministration of the proton pump inhibitor lansoprazole with levodopa, suggesting a potential drug interaction.

Withdrawal of lansoprazole resulted in the normalization of symptoms, indicating that discontinuing the medication can effectively resolve the adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Myoclonic encephalopathy associated with proton pump inhibitors]. Boulliat, J., Polard, E., Colin, F., et al.[2019]

In a Phase III study involving 239 patients with frequent GERD, Zegerid and Losec showed no significant difference in the median time to sustained heartburn relief, with both treatments taking around 60 minutes for Zegerid and 52 minutes for Losec.

However, Zegerid was found to provide sustained total relief within 0-30 minutes for significantly more patients compared to Losec, indicating a potentially faster onset of action despite overall similar efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges of correlating pH change with relief of clinical symptoms in gastro esophageal reflux disease: a phase III, randomized study of Zegerid versus Losec. Walker, D., Ng Kwet Shing, R., Jones, D., et al.[2020]

In a study of 11 pediatric patients with symptomatic inflammatory esophagogastric polyps, treatment with the proton pump inhibitor lansoprazole led to significant reductions in polyp size, from an average of 13.7 mm to 4.7 mm after 6 months.

While about 5 months of treatment was effective for symptom relief and significant size reduction, the study suggests that a longer duration of more than 7 months may be necessary for complete resolution of the polyps.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of proton pump inhibitors on pediatric inflammatory esophagogastric polyps. Choi, KE., Kim, MJ., Lee, JH., et al.[2013]

In a study involving 12 healthy male volunteers, both lansoprazole and omeprazole tablets significantly reduced gastric acid secretion, with lansoprazole 15 mg showing similar effectiveness to omeprazole 20 mg, but lansoprazole 30 mg being more effective overall.

Lansoprazole demonstrated lower variability in response among individuals compared to omeprazole, indicating it may provide more consistent acid inhibition, and both medications were well-tolerated with no significant safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial potency of lansoprazole and omeprazole tablets on pentagastrin-stimulated gastric acid secretion-a placebo-controlled study in healthy volunteers. Müller, P., Göksu, MA., Fuchs, W., et al.[2019]

Omeprazole has demonstrated unprecedented effectiveness in healing ulcers and providing symptom relief, as shown in clinical trials conducted in the UK and Scandinavia.

The drug acts rapidly and powerfully, making it challenging to establish the minimum effective dose for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of duodenal ulcer disease. Clinical results with omeprazole. Walan, A.[2019]

Omeprazole, a new drug for treating acid-related diseases, was found to be prescribed at higher doses than the established daily recommendations, indicating its strong clinical use in hospitalized patients.

The study revealed that while omeprazole was appropriately prescribed for its intended use, its substitution for H2 receptor antagonists like cimetidine and ranitidine significantly increased drug costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omeprazole. A pharmaco-epidemiological study of its use in a university hospital. Burger, DM., Hekster, YA., Hopman, WP., et al.[2019]

Omeprazole, a proton pump inhibitor used since 1989 for treating peptic ulcers and other conditions, has been found to be well tolerated in most clinical trials, with adverse effects occurring in approximately 1 in 12,200 treatments over 4 weeks.

While the drug is generally safe, some reported adverse reactions include neurological issues like confusion (especially in older patients or those with liver disease), skin rashes, and potential hematological effects, prompting health authorities to inform prescribers about these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of unexpected and toxic effects of omeprazole (Mopral) reported to the regional centers of pharmacovigilance during the first 22 postmarketing months]. Castot, A., Bidault, I., Dahan, R., et al.[2013]

On-demand therapy with rabeprazole, a proton pump inhibitor, effectively controlled symptoms in over 85% of 51 patients with mild gastroesophageal reflux disease (GERD) over a 6-month period.

Patients reported high satisfaction scores (98 out of 100 initially, 90 during therapy), and their health-related quality of life (HRQoL) normalized and was maintained, indicating that this approach is both effective and well-received by patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

On-demand therapy with rabeprazole in nonerosive and erosive gastroesophageal reflux disease in clinical practice: effectiveness, health-related quality of life, and patient satisfaction. Ponce, J., Argüello, L., Bastida, G., et al.[2019]

In a review of 646 patients treated with omeprazole for up to 5.5 years, no significant patterns of changes in gastric endocrine cells were observed, suggesting that long-term use may not necessitate routine endoscopic monitoring.

The only notable macroscopic changes were endocrine tumors found in a small subset of patients with Zollinger-Ellison syndrome, indicating that while some patients may require monitoring, the overall risk of serious gastric lesions in the general population on omeprazole is low.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is endoscopy helpful in patient monitoring? McCloy, R.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10428080/

Effectiveness of Omeprazole in Acid Peptic Disease Omeprazole therapy is safe and effective for the treatment of APD and shows good improvement in APD in patients suffering from duodenal ulcers, gastric ulcers, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10538946/

Comparing the Safety and Efficacy of Proton Pump Inhibitors ... This study compares the different side effects of PPIs and H2RAs. Most studies concluded that omeprazole is superior in healing ulcers and bringing pain relief.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0149291899800332

Lansoprazole versus omeprazole for duodenal ulcer ... Healing rates at 4 weeks (intentto-treat analysis) were 93.9% (95% confidence interval [CI], 90.2% to 97.6%) with lansoprazole and 97.5% (95% CI, 93.7% to 100%) ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2024/9990554

Efficacy and Safety of Omeprazole for the Treatment of Acid ... Primary outcomes included improvement of APD symptoms and frequency of ulcer or erosion healing. Secondary outcomes included adverse events ...

5. thelancet.com thelancet.com/journals/langas/article/PIIS2468-1253(18)30037-2/fulltext

Effects of gastroprotectant drugs for the prevention and ... Individual PPIs were all effective for endoscopic ulcer healing, but differed in their degree of effect (phet ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2012/019810s096lbl.pdf

PRILOSEC (omeprazole) Label - accessdata.fda.gov The safety data described below reflects exposure to PRILOSEC. Delayed-Release Capsules in 3096 patients from worldwide clinical trials (465 patients from US ...

7. mayoclinic.org mayoclinic.org/drugs-supplements/omeprazole-oral-route/description/drg-20066836

Omeprazole (oral route) - Side effects & dosage Omeprazole is used to treat certain conditions where there is too much acid in the stomach. It is used to treat gastric and duodenal ulcers, erosive esophagitis ...

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK539786/

Omeprazole - StatPearls - NCBI Bookshelf - NIH If an ulcer is present on initial diagnosis, then it is recommended to provide an additional 18 days of omeprazole 20 mg once daily. Clinicians should expect ...

9. drugs.com drugs.com/omeprazole.html

Omeprazole Uses, Side Effects, Dosage, Warnings Omeprazole is used to treat excess stomach acid in conditions such as non cancerous stomach ulcers, gastroesophageal reflux disease (GERD), active duodenal ...

10. reference.medscape.com reference.medscape.com/drug/prilosec-omeprazole-341997

Prilosec (omeprazole) dosing, indications, interactions, ... Duodenal Ulcer. 20 mg PO qDay for 4-8 weeks. Safety and efficacy of omeprazole for maintenance treatment past 1 year not established. Helicobacter Pylori ...