NCT03315676

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2017

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 20, 2017

Completed
12 days until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2022

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2025

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

5.1 years

First QC Date

October 7, 2017

Last Update Submit

September 20, 2021

Conditions

Gastrointestinal Erosions and/or Ulcers

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Oral Bonoprazan

ACTIVE COMPARATOR

Daily intake of Bonoprazan

Drug: Oral Bonoprazan

Oral Esomeprazol

ACTIVE COMPARATOR

Daily intake of Esomeprazol

Drug: Oral Esomeprazol

Interventions

Oral BonoprazanDRUG

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

Oral Bonoprazan
Oral EsomeprazolDRUG

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

Oral Esomeprazol

Eligibility Criteria

Age20 Years - 99 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMale patients are separately analyzed
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of NSAIDs-induced gastrointestinal Erosions and/or Ulcers who want to take Bonoprazan or Esomeprazole

You may not qualify if:

  • Patients allergic to Bonoprazan or Esomeprazole

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yukio Nakamura

Matsumoto, Nagano, 3908621, Japan

RECRUITING

MeSH Terms

Interventions

Omeprazole

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Yukio Nakamura, MD, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer at Shinshu University School of Medicine

Study Record Dates

First Submitted

October 7, 2017

First Posted

October 20, 2017

Study Start

November 1, 2017

Primary Completion

November 21, 2022

Study Completion

September 4, 2025

Last Updated

September 21, 2021

Record last verified: 2021-09

Locations

JP(1)