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
About this trial
This is an interventional treatment trial for Gastrointestinal Erosions and/or Ulcers
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
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
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
We'll reach out to this number within 24 hrs