OPEN Versus InTact Capsule Proton Pump Inhibitors for the Treatment of Marginal Ulcers
NCT ID: NCT05799105
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
122 participants
INTERVENTIONAL
2023-03-14
2025-12-23
Brief Summary
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* 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).
Detailed Description
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Proton pump inhibitors (PPIs), which act by block acid secretion from the stomach, are the gold standard for treatment of ulcers. There is limited data showing that opening the PPI capsule and taking only the contents greatly improves healing of marginal ulcers after gastric bypass surgery. This is likely due to the much smaller stomach, faster passage through the stomach and decreased ability of the intact PPI medication to be broken down and absorbed.
This would be the first clinical trial to confirm whether this is true, which would support all patients who get ulcers after gastric bypass surgery to be treated with open-capsule PPI medications.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Open-capsule
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.
Omeprazole 40 milligrams
Subjects will be randomized to treatment with either open-capsule or intact-capsule omeprazole to assess effect on ulcer healing times. If interim analysis illustrates significantly improved healing in the open-capsule group, the control (intact-capsule) arm will be allowed to cross-over to open-capsule and be followed until confirmed ulcer healing.
Intact-capsule
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 40 milligrams
Subjects will be randomized to treatment with either open-capsule or intact-capsule omeprazole to assess effect on ulcer healing times. If interim analysis illustrates significantly improved healing in the open-capsule group, the control (intact-capsule) arm will be allowed to cross-over to open-capsule and be followed until confirmed ulcer healing.
Interventions
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Omeprazole 40 milligrams
Subjects will be randomized to treatment with either open-capsule or intact-capsule omeprazole to assess effect on ulcer healing times. If interim analysis illustrates significantly improved healing in the open-capsule group, the control (intact-capsule) arm will be allowed to cross-over to open-capsule and be followed until confirmed ulcer healing.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Stephen Firkins
OTHER
Responsible Party
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Stephen Firkins
Co-Director of Bariatric Endoscopy
Principal Investigators
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Stephen Firkins, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleveland Clinic Foundation
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Stephen Firkins, MD
Role: primary
References
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Pyke O, Yang J, Cohn T, Yin D, Docimo S, Talamini MA, Bates AT, Pryor A, Spaniolas K. Marginal ulcer continues to be a major source of morbidity over time following gastric bypass. Surg Endosc. 2019 Oct;33(10):3451-3456. doi: 10.1007/s00464-018-06618-5. Epub 2018 Dec 12.
Di Palma A, Liu B, Maeda A, Anvari M, Jackson T, Okrainec A. Marginal ulceration following Roux-en-Y gastric bypass: risk factors for ulcer development, recurrence and need for revisional surgery. Surg Endosc. 2021 May;35(5):2347-2353. doi: 10.1007/s00464-020-07650-0. Epub 2020 May 18.
Tansel A, Graham DY. New Insight Into an Effective Treatment of Marginal Ulceration After Roux-en-Y Gastric Bypass. Clin Gastroenterol Hepatol. 2017 Apr;15(4):501-503. doi: 10.1016/j.cgh.2016.12.025. Epub 2017 Jan 3. No abstract available.
English WJ, DeMaria EJ, Hutter MM, Kothari SN, Mattar SG, Brethauer SA, Morton JM. American Society for Metabolic and Bariatric Surgery 2018 estimate of metabolic and bariatric procedures performed in the United States. Surg Obes Relat Dis. 2020 Apr;16(4):457-463. doi: 10.1016/j.soard.2019.12.022. Epub 2020 Jan 3.
Coblijn UK, Goucham AB, Lagarde SM, Kuiken SD, van Wagensveld BA. Development of ulcer disease after Roux-en-Y gastric bypass, incidence, risk factors, and patient presentation: a systematic review. Obes Surg. 2014 Feb;24(2):299-309. doi: 10.1007/s11695-013-1118-5.
Ribeiro-Parenti L, Arapis K, Chosidow D, Marmuse JP. Comparison of marginal ulcer rates between antecolic and retrocolic laparoscopic Roux-en-Y gastric bypass. Obes Surg. 2015 Feb;25(2):215-21. doi: 10.1007/s11695-014-1392-x.
Schulman AR, Chan WW, Devery A, Ryan MB, Thompson CC. Opened Proton Pump Inhibitor Capsules Reduce Time to Healing Compared With Intact Capsules for Marginal Ulceration Following Roux-en-Y Gastric Bypass. Clin Gastroenterol Hepatol. 2017 Apr;15(4):494-500.e1. doi: 10.1016/j.cgh.2016.10.015. Epub 2016 Oct 20.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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23-024
Identifier Type: -
Identifier Source: org_study_id