Omeprazole for Ulcers (OPEN-IT Trial)

Phase 4

Recruiting

Led By C. Roberto Simons-Linares, MD

Research Sponsored by Carlos Roberto Simons-Linares

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up on average, 3 months to 12 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial seeks to find the best way to take acid-blocking medications to treat stomach ulcers in people who have had gastric bypass surgery, to reduce the need for procedures and complications.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Common side effects of Omeprazole include headaches, stomach pain, nausea, diarrhea, vomiting, and gas. Long-term use can lead to vitamin B12 deficiency or bone fractures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ on average, 3 months to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~on average, 3 months to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and on average, 3 months to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ulcer healing

Secondary study objectives

Ulcer healing time

pH of gastric pouch

Awards & Highlights

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.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Open-capsuleExperimental Treatment1 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-capsuleActive Control1 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.

Do I qualify?Apply below to find out