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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03315676
Recruitment Status : Recruiting
First Posted : October 20, 2017
Last Update Posted : November 22, 2018
Information provided by (Responsible Party):
Yukio Nakamura, 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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Erosions and/or Ulcers Drug: Oral Bonoprazan Drug: Oral Esomeprazol Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: RCT Using Bonopurazan or Esomeprazole in Patients With NSAIDs-induced Erosions and/or Ulcers
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : November 21, 2019
Estimated Study Completion Date : September 4, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Oral Bonoprazan
Daily intake of Bonoprazan
Drug: Oral Bonoprazan
To examine the efficacy of oral Bonoprazan in patients with NSAIDs-induced Erosions and/or Ulcers

Active Comparator: Oral Esomeprazol
Daily intake of Esomeprazol
Drug: Oral Esomeprazol
To examine the efficacy of oral Esomeprazol in patients with NSAIDs-induced Erosions and/or Ulcers

Primary Outcome Measures :
  1. Number of participants with healing of gastrointestinal erosions and/or ulcers using major forceps [ Time Frame: Change from Baseline Gastrointestinal erosions and/or ulcers at 2 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male patients are separately analyzed
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03315676

Contact: Yukio Nakamura, MD, PhD +81-263-37-2659

Yukio Nakamura Recruiting
Matsumoto, Nagano, Japan, 3908621
Contact: Yukio Nakamura, MD, PhD    +81-263-37-2659   
Principal Investigator: Yukio Nakamura, MD, PhD         
Sponsors and Collaborators
Shinshu University

Responsible Party: Yukio Nakamura, Lecturer at Shinshu University School of Medicine, Shinshu University Identifier: NCT03315676     History of Changes
Other Study ID Numbers: PPI 2017
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pathologic Processes
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents