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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03315676

Enrollment

124

Registered

2017-10-20

Start date

2017-11-01

Completion date

2025-09-04

Last updated

2021-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Erosions and/or Ulcers

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.

Interventions

DRUGOral Bonoprazan

To examine the efficacy of oral Bonoprazan in patients with NSAIDs-induced Erosions and/or Ulcers

DRUGOral Esomeprazol

To examine the efficacy of oral Esomeprazol in patients with NSAIDs-induced Erosions and/or Ulcers

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 99 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Japan

Contacts

Primary ContactYukio Nakamura, MD, PhD

yxn14@aol.jp+81-263-37-2659

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026