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

Primary Purpose

Gastrointestinal Erosions and/or Ulcers

Status
Recruiting
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Oral Bonoprazan
Oral Esomeprazol
Sponsored by
Shinshu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Erosions and/or Ulcers

Eligibility Criteria

20 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Yukio NakamuraRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Oral Bonoprazan

Oral Esomeprazol

Arm Description

Daily intake of Bonoprazan

Daily intake of Esomeprazol

Outcomes

Primary Outcome Measures

Number of participants with healing of gastrointestinal erosions and/or ulcers using major forceps

Secondary Outcome Measures

Full Information

First Posted
October 7, 2017
Last Updated
September 20, 2021
Sponsor
Shinshu University
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1. Study Identification

Unique Protocol Identification Number
NCT03315676
Brief Title
Efficacy of Proton Pump Inhibitors in Gastrointestinal Erosions and/or Ulcers
Official Title
RCT Using Bonopurazan or Esomeprazole in Patients With NSAIDs-induced Erosions and/or Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
November 21, 2022 (Anticipated)
Study Completion Date
September 4, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shinshu University

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Erosions and/or Ulcers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oral Bonoprazan
Arm Type
Active Comparator
Arm Description
Daily intake of Bonoprazan
Arm Title
Oral Esomeprazol
Arm Type
Active Comparator
Arm Description
Daily intake of Esomeprazol
Intervention Type
Drug
Intervention Name(s)
Oral Bonoprazan
Intervention Description
To examine the efficacy of oral Bonoprazan in patients with NSAIDs-induced Erosions and/or Ulcers
Intervention Type
Drug
Intervention Name(s)
Oral Esomeprazol
Intervention Description
To examine the efficacy of oral Esomeprazol in patients with NSAIDs-induced Erosions and/or Ulcers
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Male patients are separately analyzed
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yukio Nakamura, MD, PhD
Phone
+81-263-37-2659
Email
yxn14@aol.jp
Facility Information:
Facility Name
Yukio Nakamura
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
3908621
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yukio Nakamura, MD, PhD
Phone
+81-263-37-2659
Email
yxn14@aol.jp
First Name & Middle Initial & Last Name & Degree
Yukio Nakamura, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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