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

PHASE4RecruitingINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

March 14, 2023

Primary Completion Date

December 23, 2025

Study Completion Date

December 23, 2025

Conditions
Marginal Ulcer
Interventions
DRUG

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.

Trial Locations (1)

44195

RECRUITING

Cleveland Clinic Foundation, Cleveland

All Listed Sponsors
lead

Carlos Roberto Simons-Linares

OTHER