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

Conditions

• Marginal Ulcer

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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).

Key Dates

Start date

Mar 14, 2023

Status verified

Mar 2026

Primary completion

Mar 23, 2027

Completion

Mar 23, 2027

Study Design

Enrollment

122 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 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.
• Active Comparator: 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.

Primary Outcome Measure

Ulcer healing [ Time Frame: On average, 3 months to 12 months ]

Central Contacts

• Stephen Firkins, MD
  216-444-8460
  [email protected]

Locations (1)

Find similar trials in Cleveland, OH

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