Health TrialsbyHealthPanel

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

ConditionMarginal Ulcer
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorStephen Firkins

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

122 Participants
are divided into 2 treatment groups
Group A: Open-capsuleExperimental treatment 1 intervention
Group B: Intact-capsuleActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Ulcer healing

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 outcomes

1

Ulcer healing time

Time to ulcer healing, defined as (date of ulcer healing) - (date of ulcer diagnosis)

Time frame
On average, 3 months to 12 months
2

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.

Time frame
Upon initial enrollment endoscopy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stephen Firkins

Lead sponsor

The Cleveland Clinic

Sponsor institution

Source ClinicalTrials.gov
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