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

Phase 2

Recruiting

• Conditions: Gastrointestinal Erosions and/or Ulcers
• Interventions: Drug: Oral Bonoprazan; Drug: Oral Esomeprazol

• Registration Number: NCT03315676
• Lead Sponsor: Shinshu University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-07
• Study First Submitted QC: 2017-10-16
• Study First Posted: 2017-10-20
• Study Start: 2017-11-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-21
• Primary Completion: 2022-11-21
• Study Completion: 2025-09-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 124

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Bonoprazan	Oral Bonoprazan	Daily intake of Bonoprazan
Oral Esomeprazol	Oral Esomeprazol	Daily intake of Esomeprazol

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Yukio Nakamura; 🇯🇵 Matsumoto, Nagano, Japan