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OPEN Versus InTact Capsule Proton Pump Inhibitors for the Treatment of Marginal Ulcers (OPEN-IT)

Primary Purpose

Marginal Ulcer

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Omeprazole 40 milligrams
Sponsored by
Carlos Roberto Simons-Linares
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Marginal Ulcer focused on measuring marginal ulcer, bariatric surgery, gastric bypass, open capsule

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects diagnosed with marginal ulceration post-gastric bypass on upper endoscopy Exclusion Criteria: Refusal to start PPI medication OR current open-capsule PPI use at the time of diagnosis of the marginal ulcer

Sites / Locations

  • Cleveland Clinic FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Open-capsule

Intact-capsule

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Ulcer healing time
Time to ulcer healing, defined as (date of ulcer healing) - (date of ulcer diagnosis)
pH of gastric pouch
pH of the gastric pouch fluid will be obtained during initial endoscopy and tested with litmus paper. pH data will be compared between the two treatment arms.

Full Information

First Posted
February 28, 2023
Last Updated
March 22, 2023
Sponsor
Carlos Roberto Simons-Linares
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1. Study Identification

Unique Protocol Identification Number
NCT05799105
Brief Title
OPEN Versus InTact Capsule Proton Pump Inhibitors for the Treatment of Marginal Ulcers
Acronym
OPEN-IT
Official Title
OPEN Versus InTact Capsule Proton Pump Inhibitors for the Treatment of Marginal Ulcers After Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2023 (Actual)
Primary Completion Date
December 23, 2024 (Anticipated)
Study Completion Date
December 23, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Carlos Roberto Simons-Linares

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
Marginal ulcers (ulcers formed at the surgery site between the stomach and the intestines) are a common complication of bariatric surgery, ranging in frequency from 0.6-25% of patients. Furthermore, roughly 17% of patients with marginal ulcers require repeat procedures or surgery for severe complications such as bleeding, perforation, stricture, and fistulas. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marginal Ulcer
Keywords
marginal ulcer, bariatric surgery, gastric bypass, open capsule

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
prospective single-blinded randomized control trial
Masking
Care ProviderInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
122 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open-capsule
Arm Type
Experimental
Arm Description
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.
Arm Title
Intact-capsule
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Omeprazole 40 milligrams
Other Intervention Name(s)
Prilosec, Losec
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ulcer healing
Description
Rate of ulcer healing in each treatment arm, defined as resolution of previously-seen ulcer on upper endoscopy
Time Frame
On average, 3 months to 12 months
Secondary Outcome Measure Information:
Title
Ulcer healing time
Description
Time to ulcer healing, defined as (date of ulcer healing) - (date of ulcer diagnosis)
Time Frame
On average, 3 months to 12 months
Title
pH of gastric pouch
Description
pH of the gastric pouch fluid will be obtained during initial endoscopy and tested with litmus paper. pH data will be compared between the two treatment arms.
Time Frame
Upon initial enrollment endoscopy

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects diagnosed with marginal ulceration post-gastric bypass on upper endoscopy Exclusion Criteria: Refusal to start PPI medication OR current open-capsule PPI use at the time of diagnosis of the marginal ulcer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
C. Roberto Simons-Linares, MD
Phone
216-978-7264
Email
simonsc@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C. Roberto Simons-Linares, MD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
C. Roberto Simons-Linares, MD
Phone
216-978-7264
Email
simonsc@ccf.org

12. IPD Sharing Statement

Citations:
PubMed Identifier
32029370
Citation
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.
Results Reference
background
PubMed Identifier
24234733
Citation
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.
Results Reference
background
PubMed Identifier
25085224
Citation
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.
Results Reference
background
PubMed Identifier
30543040
Citation
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.
Results Reference
background
PubMed Identifier
32424625
Citation
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.
Results Reference
background
PubMed Identifier
28062217
Citation
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.
Results Reference
background
PubMed Identifier
27773764
Citation
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.
Results Reference
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OPEN Versus InTact Capsule Proton Pump Inhibitors for the Treatment of Marginal Ulcers

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