Gastrointestinal Erosions and/or UlcersPhase 2NCT03315676
Efficacy of Proton Pump Inhibitors in Gastrointestinal Erosions and/or Ulcers
A Phase 2 study testing Oral Bonoprazan and Oral Esomeprazol in people with Gastrointestinal Erosions and/or Ulcers, run by Shinshu University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Erosions and/or Ulcers
- What is being tested?
- Oral Bonoprazan and Oral Esomeprazol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteJapan
- Study dates
- 1 Nov 2017to 4 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of NSAIDs-induced gastrointestinal Erosions and/or Ulcers who want to take Bonoprazan or Esomeprazole
Who cannot join
- Patients allergic to Bonoprazan or Esomeprazole
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Yukio Nakamura
Matsumoto, Nagano, 3908621
Yukio Nakamura, MD, PhD, +81-263-37-2659, yxn14@aol.jp
Yukio Nakamura, MD, PhD
About this study
Official title: RCT Using Bonopurazan or Esomeprazole in Patients With NSAIDs-induced Erosions and/or Ulcers
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.
- Conditions
- Gastrointestinal Erosions and/or Ulcers
- Being tested
- Oral Bonoprazan, Oral Esomeprazol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral BonoprazanDrug
To examine the efficacy of oral Bonoprazan in patients with NSAIDs-induced Erosions and/or Ulcers
Oral EsomeprazolDrug
To examine the efficacy of oral Esomeprazol in patients with NSAIDs-induced Erosions and/or Ulcers
| Study group | Role | What they receive |
|---|---|---|
| Oral Bonoprazan | Active comparator | Daily intake of Bonoprazan Receives: Drug: Oral Bonoprazan |
| Oral Esomeprazol | Active comparator | Daily intake of Esomeprazol Receives: Drug: Oral Esomeprazol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with healing of gastrointestinal erosions and/or ulcers using major forceps
Measured: Change from Baseline Gastrointestinal erosions and/or ulcers at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start1 Nov 2017
- Primary completion21 Nov 2022 (estimated)
- Study completion4 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Erosions and/or UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shinshu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yukio Nakamura, Shinshu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315676
- Sponsor's protocol ID
- PPI 2017
- Status last verified
- Sep 2021
- First submitted
- 7 Oct 2017
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT Using Bonopurazan or Esomeprazole in Patients With NSAIDs-induced Erosions and/or Ulcers
- ClinicalTrials.gov ID
- NCT03315676
- Acronym / sponsor ID
- PPI 2017
- Conditions
- Gastrointestinal Erosions and/or Ulcers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Shinshu UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 21 Nov 2022 (estimated)
- Study completion
- 4 Sep 2025 (estimated)
- First posted
- 20 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Bonoprazan | Active comparator | Drug: Oral BonoprazanDaily intake of Bonoprazan |
| Oral Esomeprazol | Active comparator | Drug: Oral EsomeprazolDaily intake of Esomeprazol |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of NSAIDs-induced gastrointestinal Erosions and/or Ulcers who want to take Bonoprazan or Esomeprazole
Key exclusion criteria (1 listed)
- Patients allergic to Bonoprazan or Esomeprazole
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral BonoprazanTo examine the efficacy of oral Bonoprazan in patients with NSAIDs-induced Erosions and/or Ulcers | Drug | Oral Bonoprazan |
| Oral EsomeprazolTo examine the efficacy of oral Esomeprazol in patients with NSAIDs-induced Erosions and/or Ulcers | Drug | Oral Esomeprazol |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral Bonoprazan and Oral Esomeprazol in people with Gastrointestinal Erosions and/or Ulcers, run by Shinshu University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yukio Nakamura, MD, PhD (+81-263-37-2659, yxn14@aol.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.