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

Gastrointestinal Erosions and/or Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03315676
• Other study ID #: PPI 2017
• Status: Recruiting
• Phase: Phase 2
• Start date: November 1, 2017
• Est. completion date: September 4, 2025

Study information

• Verified date: September 2021
• Source: Shinshu University
• Contact: Yukio Nakamura, MD, PhD
• Phone: +81-263-37-2659
• Email: yxn14[@]aol.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: September 4, 2025
• Est. primary completion date: November 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Erosions and/or Ulcers
• Ulcer

Intervention

Drug:
• Oral Bonoprazan
To examine the efficacy of oral Bonoprazan in patients with NSAIDs-induced Erosions and/or Ulcers
• Oral Esomeprazol
To examine the efficacy of oral Esomeprazol in patients with NSAIDs-induced Erosions and/or Ulcers

Locations

Country	Name	City	State
Japan	Yukio Nakamura	Matsumoto	Nagano

Sponsors (1)

Lead Sponsor	Collaborator
Shinshu University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with healing of gastrointestinal erosions and/or ulcers using major forceps		Change from Baseline Gastrointestinal erosions and/or ulcers at 2 weeks