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

NCT ID: NCT03315676

Last Updated: 2021-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2025-09-04

Brief Summary

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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

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Conditions

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Gastrointestinal Erosions and/or Ulcers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Oral Bonoprazan

Daily intake of Bonoprazan

Group Type ACTIVE_COMPARATOR

Oral Bonoprazan

Intervention Type DRUG

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

Oral Esomeprazol

Daily intake of Esomeprazol

Group Type ACTIVE_COMPARATOR

Oral Esomeprazol

Intervention Type DRUG

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

Interventions

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Oral Bonoprazan

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

Intervention Type DRUG

Oral Esomeprazol

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shinshu University

OTHER

Sponsor Role lead

Responsible Party

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Yukio Nakamura

Lecturer at Shinshu University School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yukio Nakamura

Matsumoto, Nagano, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Yukio Nakamura, MD, PhD

Role: CONTACT

+81-263-37-2659

Facility Contacts

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Yukio Nakamura, MD, PhD

Role: primary

+81-263-37-2659

Other Identifiers

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PPI 2017

Identifier Type: -

Identifier Source: org_study_id

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