Efficacy of Proton Pump Inhibitors in Gastrointestinal Erosions and/or Ulcers

September 20, 2021 updated by: Yukio Nakamura, Shinshu University

RCT Using Bonopurazan or Esomeprazole in Patients With NSAIDs-induced Erosions and/or Ulcers

The aim of this study is to collect the data of clinical efficacy and safety after the usage of bonoprazon and esomeprazole when the patients take NSAIDs more than 2 weeks and have gastrointestinal symptoms who have had gastrointestinal erosions and/or ulcers in the past.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

124

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Nagano
      • Matsumoto, Nagano, Japan, 3908621
        • Recruiting
        • Yukio Nakamura

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of NSAIDs-induced gastrointestinal Erosions and/or Ulcers who want to take Bonoprazan or Esomeprazole

Exclusion Criteria:

  • Patients allergic to Bonoprazan or Esomeprazole

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Oral Bonoprazan
Daily intake of Bonoprazan
Drug: Oral Bonoprazan
To examine the efficacy of oral Bonoprazan in patients with NSAIDs-induced Erosions and/or Ulcers
ACTIVE_COMPARATOR: Oral Esomeprazol
Daily intake of Esomeprazol
Drug: Oral Esomeprazol
To examine the efficacy of oral Esomeprazol in patients with NSAIDs-induced Erosions and/or Ulcers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with healing of gastrointestinal erosions and/or ulcers using major forceps
Time Frame: Change from Baseline Gastrointestinal erosions and/or ulcers at 2 weeks
Change from Baseline Gastrointestinal erosions and/or ulcers at 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shinshu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2017

Primary Completion (ANTICIPATED)

November 21, 2022

Study Completion (ANTICIPATED)

September 4, 2025

Study Registration Dates

First Submitted

October 7, 2017

First Submitted That Met QC Criteria

October 16, 2017

First Posted (ACTUAL)

October 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 20, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPI 2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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