Omeprazole for Ulcers

(OPEN-IT Trial)

Recruiting in Palo Alto (17 mi)

Overseen by C. Roberto Simons-Linares, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Carlos Roberto Simons-Linares

Must be taking: Proton-pump inhibitors

Disqualifiers: Refusal PPI, Current open-capsule PPI

No Placebo Group

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to identify the most effective way to take acid-blocking medications to treat stomach ulcers in patients who have undergone gastric bypass surgery. The main questions it aims to answer are: * is taking an acid-blocking medication by opening the capsule and only taking the contents of the capsule (open-capsule) more or less effective than taking the capsule as a whole (intact-capsule) for treating ulcers in patients who have a history of gastric bypass surgery? * does taking the open versus intact medication decrease the number of procedures and complications from untreated ulcers? Participants with ulcers will be instructed to take acid-blocking medications (called proton-pump inhibitors) either by opening the capsule and taking only the contents or by taking the capsule whole. These medications are the gold standard for treatment of stomach ulcers. Participants will be asked to undergo an upper endoscopy (EGD) every 3 months to monitor the healing of the ulcers. Researchers will compare how quickly the ulcers heal depending on which way the medications are taken (opened up or as a whole).

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 data supports the effectiveness of the drug Omeprazole for ulcers?

Research shows that Omeprazole is highly effective in healing duodenal ulcers, with 16 out of 17 ulcers healed after four weeks of treatment. It also provides rapid relief of symptoms, making it a powerful option for treating acid-related conditions. ^{1 2 3 4 5}

Is omeprazole generally safe for humans?

Omeprazole is generally considered safe for short-term use, with common side effects including headache, dizziness, skin rash, and constipation. Some rare side effects have been reported, such as confusion in older adults or those with liver issues, and mild liver enzyme changes, but these are infrequent. ^{1 2 4 6 7}

How does the drug omeprazole differ from other treatments for ulcers?

Omeprazole is a proton pump inhibitor (PPI) that reduces stomach acid production, which is different from other ulcer treatments like antacids that neutralize existing acid. It is often used for long-term management and has been shown to be safe for continuous use up to 5 years without the need for regular endoscopic monitoring. ^{8 9 10 11 12}

Research Team

C. Roberto Simons-Linares, MD

Principal Investigator

Assistant Professor

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Omeprazole (Proton Pump Inhibitor)

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.

Participant Groups

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 Canada, Japan, China, Switzerland for the following indications:

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?

Carlos Roberto Simons-Linares

Lead Sponsor

Trials

2

Recruited

190+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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 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]

References

1. United States 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. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Omeprazole. A pharmaco-epidemiological study of its use in a university hospital. [2019]

3. England 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. [2019]

4. Czech Republic pubmed.ncbi.nlm.nih.gov

[The effect of omeprazole on healing of duodenal ulcers, Helicobacter pylori and gastritis]. [2020]

5. England pubmed.ncbi.nlm.nih.gov

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

6. Switzerland pubmed.ncbi.nlm.nih.gov

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

7. France 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]. [2013]

8. United States 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. [2019]

9. France pubmed.ncbi.nlm.nih.gov

[Myoclonic encephalopathy associated with proton pump inhibitors]. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Is endoscopy helpful in patient monitoring? [2018]

11. England pubmed.ncbi.nlm.nih.gov

Safety aspects of omeprazole. [2019]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of proton pump inhibitors on pediatric inflammatory esophagogastric polyps. [2013]