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Proton Pump Inhibitor
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
OPEN-IT Trial 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.Check my eligibility
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.See study design
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.
OPEN-IT Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ulcer healing
Secondary outcome measures
Ulcer healing time
pH of gastric pouch
OPEN-IT 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.
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Who is running the clinical trial?
Carlos Roberto Simons-LinaresLead Sponsor
1 Previous Clinical Trials
70 Total Patients Enrolled
C. Roberto Simons-Linares, MDPrincipal InvestigatorAssistant Professor
1 Previous Clinical Trials
70 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I refuse to take PPI medication.I am currently using open-capsule PPIs for my ulcer.I have been diagnosed with ulcers after gastric bypass surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Open-capsule
- Group 2: Intact-capsule
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the potential risks associated with using Open-capsule?
"The safety of Open-capsule has been assessed and scored a 3, as this is an approved Phase 4 trial."
Answered by AI
Is registration for this clinical experiment still open?
"Yes, the details available on clinicaltrials.gov indicate that this experiment is actively trying to acquire participants. Initially posted on March 14th 2023, it was revised most recently on March 22nd and requires 122 patients from one centre."
Answered by AI
What is the cap for enrolment in this research project?
"Verified. According to the data posted on clinicaltrials.gov, this medical trial that was first published on March 14th 2023 is presently recruiting patients and has most recently been updated on March 22nd 2023. 122 individuals must be sourced from 1 site for participation in this experiment."
Answered by AI
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