Efficacy of Proton Pump Inhibitors in Gastrointestinal Er... | NCT03315676

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

NCT03315676

Sponsor

Shinshu University

Status

Unknown status

Last Update Posted

Sep 21, 2021Actual

Enrollment

124Estimated

Phase

Phase 2

Conditions

Gastrointestinal Erosions and/or Ulcers

Interventions

Oral Bonoprazan
Oral Esomeprazol

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2017Actual

Primary Completion Date

Nov 21, 2022Estimated

Completion Date

Sep 4, 2025Estimated

First Submitted Date

Oct 7, 2017

First Submission Date that Met QC Criteria

Oct 16, 2017

First Posted Date

Oct 20, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2021

Last Update Posted Date

Sep 21, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yukio Nakamura, Lecturer at Shinshu University School of Medicine, Shinshu UniversityPrincipal Investigator

Lead Sponsor

Shinshu UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

124Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oral Bonoprazan	Active Comparator	Daily intake of Bonoprazan	Drug: Oral Bonoprazan
Oral Esomeprazol	Active Comparator	Daily intake of Esomeprazol	Drug: Oral Esomeprazol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oral Bonoprazan	Drug	To examine the efficacy of oral Bonoprazan in patients with NSAIDs-induced Erosions and/or Ulcers	Oral Bonoprazan

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Male patients are separately analyzed

Minimum Age

20 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yukio Nakamura, MD, PhD	Contact	+81-263-37-2659		yxn14@aol.jp

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yukio Nakamura	Recruiting	Matsumoto	Nagano	3908621	Japan

Intervention Browse Module

MeSH Terms

ID	Term
D009853	Omeprazole

Ancestor Terms

ID	Term
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided