OPEN Versus InTact Capsule Proton Pump Inhibitors for the Treatment of Marginal Ulcers

NCT05799105 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 23-024
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Marginal Ulcer

Keywords

marginal ulcer; bariatric surgery; gastric bypass; open capsule

Outcome Measures

Primary Outcomes (1)

• Ulcer healing

  Rate of ulcer healing in each treatment arm, defined as resolution of previously-seen ulcer on upper endoscopy

  On average, 3 months to 12 months

Secondary Outcomes (2)

• Ulcer healing time

  On average, 3 months to 12 months

• pH of gastric pouch

  Upon initial enrollment endoscopy

Study Arms (2)

Open-capsule

EXPERIMENTAL

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.

Drug: Omeprazole 40 milligrams

Intact-capsule

ACTIVE COMPARATOR

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.

Drug: Omeprazole 40 milligrams

Interventions

Omeprazole 40 milligrams DRUG

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.

Also known as: Prilosec, Losec

Intact-capsule; Open-capsule

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects diagnosed with marginal ulceration post-gastric bypass on upper endoscopy

You may not qualify if:

• Refusal to start PPI medication OR current open-capsule PPI use at the time of diagnosis of the marginal ulcer

Sponsors & Collaborators

• Stephen Firkins: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Related Publications (7)

• 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.

  PMID: 32029370 BACKGROUND

• 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.

  PMID: 24234733 BACKGROUND

• 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.

  PMID: 25085224 BACKGROUND

• 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.

  PMID: 30543040 BACKGROUND

• 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.

  PMID: 32424625 BACKGROUND

• 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.

  PMID: 28062217 BACKGROUND

• 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.

  PMID: 27773764 BACKGROUND

MeSH Terms

Conditions

Peptic Ulcer

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Stephen Firkins, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Firkins, MD

CONTACT

216-444-8460; bariatricendoscopy@ccf.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Endoscopists diagnosing and surveying healing of marginal ulcers will be blinded to the subject's treatment arm. A single, unmasked provider will be responsible for randomizing and prescribing either open- or intact-capsule PPI after subjects are enrolled in the study. This unmasked provider will not take part in diagnosis, monitoring or assessment of ulcer healing, or in data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Director of Bariatric Endoscopy

Model Details: prospective single-blinded randomized control trial

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: April 5, 2023
• Study Start: March 14, 2023
• Primary Completion (Estimated): March 23, 2027
• Study Completion (Estimated): March 23, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

US (1)