Gastric or Duodenal UlcersNCT03214094

Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use"

An observational study of Gastric or Duodenal Ulcers, run by Takeda at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this survey is to investigate the safety and effectiveness of long-term administration of vonoprazan tablets for up to 12 months in the routine clinical setting in patients receiving low-dose aspirin. Read more about this study

Who is it for?: Any age
Conditions the study is for: Gastric or Duodenal Ulcers
What is being tested?: Vonoprazan
Type of treatment: Pill or oral medicine
How many people: 1,119 participants
Where: 1 siteJapan
Study dates: 1 Sep 2016to 28 Feb 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: The survey population will consist of participants with a diagnosis of gastric or duodenal ulcers and during low-dose aspirin administration in the routine medical care.

Who may be able to join

Participants with a history of gastric or duodenal ulcer

Who cannot join

Participants with gastric or duodenal ulcer at initiation of vonoprazan therapy
Participants with active upper gastrointestinal hemorrhage at initiation vonoprazan therapy
Participants with a history of hypersensitivity to any ingredients in vonoprazan Tablets
Participants receiving atazanavir sulfate or rilpivirine hydrochloride

Trial locations and contacts

1 site in 1 country.

Japan1 site

Takeda Selected Site
Tokyo

Other trials in Japan

About this study

Official title: Special Drug Use Surveillance of Takecab Tablets for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use"

Read the detailed description

The drug being tested in this survey is called vonoprazan. Vonoprazan is being tested to treat people who have gastric or duodenal ulcers.

This survey will look at the safety and effectiveness of long-term administration of vonoprazan tablets for up to 12 months in the routine clinical setting in patients receiving low-dose aspirin.

The survey will enroll approximately 1,000 participants.

Vonoprazan 10 mg

This multi-center observational survey will be conducted in Japan.

Conditions: Gastric or Duodenal Ulcers
Being tested: Vonoprazan
Medical subject headings: Duodenal Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VonoprazanDrug
Also called Takecab tablets, TAK-438
Vonoprazan tablets

Study groups in NCT03214094
Study group	Role	What they receive
Vonoprazan 10 mg		The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily. Participants will receive interventions as part of routine medical care. Receives: Drug: Vonoprazan

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Who Had One or More Adverse Drug Reactions
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.
Measured: Up to 12 months

Secondary outcomes (4)

Percentage of Participants With Gastric Ulcers After the Start of Administration of Vonoprazan Tablets
Reported data were percentage of participants who experienced an onset of gastric ulcers after the start of administration of vonoprazan tablets.
Measured: Up to 12 months
Percentage of Participants With Duodenal Ulcers After the Start of Administration of Vonoprazan Tablets
Reported data were percentage of participants who experienced an onset of duodenal ulcers after the start of administration of vonoprazan tablets.
Measured: Up to 12 months
Percentage of Participants With Hemorrhagic Lesions on Stomach After the Start of Administration of Vonoprazan Tablets
Reported data were percentage of participants who had hemorrhagic lesions on stomach after the start of administration of vonoprazan tablets.
Measured: Up to 12 months
Percentage of Participants With Hemorrhagic Lesions on Duodenum After the Start of Administration of Vonoprazan Tablets
Reported data were percentage of participants who had hemorrhagic lesions on duodenum after the start of administration of vonoprazan tablets.
Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201628 Feb 2019

First posted11 Jul 2017
Study start1 Sep 2016
Primary completion28 Feb 2019
Study completion28 Feb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Gastric or Duodenal UlcersStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,119 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03214094
Sponsor's protocol ID: Vonoprazan-5004
Other IDs: JapicCTI-163435
Status last verified: Feb 2020
First submitted: 9 Jul 2017
Last updated: 11 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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The Transit Bipartition With the Use of a Metallic Anastomosis Clip and Circular Fundocorporeal Gastroplication
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All Gastric or Duodenal Ulcers trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Special Drug Use Surveillance of Takecab Tablets for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use"
ClinicalTrials.gov ID: NCT03214094
Acronym / sponsor ID: Vonoprazan-5004
Conditions: Gastric or Duodenal Ulcers
Study type: Observational
Recruitment status: Completed
Enrolment: 1,119 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 1 Sep 2016 (actual)
Primary completion: 28 Feb 2019 (actual)
Study completion: 28 Feb 2019 (actual)
First posted: 11 Jul 2017 (actual)
Results: Posted 11 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The drug being tested in this survey is called vonoprazan. Vonoprazan is being tested to treat people who have gastric or duodenal ulcers.

This survey will look at the safety and effectiveness of long-term administration of vonoprazan tablets for up to 12 months in the routine clinical setting in patients receiving low-dose aspirin.

The survey will enroll approximately 1,000 participants.

Vonoprazan 10 mg

This multi-center observational survey will be conducted in Japan.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Vonoprazan 10 mg	–	Drug: VonoprazanThe usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily. Participants will receive interventions as part of routine medical care.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: The survey population will consist of participants with a diagnosis of gastric or duodenal ulcers and during low-dose aspirin administration in the routine medical care.

Key inclusion criteria (1 listed)

Participants with a history of gastric or duodenal ulcer

Key exclusion criteria (4 listed)

Participants with gastric or duodenal ulcer at initiation of vonoprazan therapy
Participants with active upper gastrointestinal hemorrhage at initiation vonoprazan therapy
Participants with a history of hypersensitivity to any ingredients in vonoprazan Tablets
Participants receiving atazanavir sulfate or rilpivirine hydrochloride

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
VonoprazanAlso: Takecab tablets, TAK-438Vonoprazan tablets	Drug	Vonoprazan 10 mg

Primary outcome

Percentage of Participants Who Had One or More Adverse Drug Reactions
Time frame: Up to 12 months
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.

4 secondary outcomes

Percentage of Participants With Gastric Ulcers After the Start of Administration of Vonoprazan Tablets
Time frame: Up to 12 months
Percentage of Participants With Duodenal Ulcers After the Start of Administration of Vonoprazan Tablets
Time frame: Up to 12 months
Percentage of Participants With Hemorrhagic Lesions on Stomach After the Start of Administration of Vonoprazan Tablets
Time frame: Up to 12 months
Percentage of Participants With Hemorrhagic Lesions on Duodenum After the Start of Administration of Vonoprazan Tablets
Time frame: Up to 12 months

Results and safety

Results posted to the registry on 11 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vonoprazan 10 mg	1,119	1,059

Primary outcome: Percentage of Participants Who Had One or More Adverse Drug Reactions

Time frame: Up to 12 months. Number. Unit: Percentage of Participants

Measure	Vonoprazan 10 mg n = 1059
Value	1.79

Population analysed: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 12 months. Other adverse events reported at 0.3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vonoprazan 10 mg	50 of 1,059 (4.7%)	4 of 1,059 (0.4%)	9 of 1,059

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Related trials for Gastric or Duodenal Ulcers

Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
Recruiting
Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment
Roux-en-y Anastomosis Site, Marginal Ulcer
RecruitingPhase 4
The Bioavailability and Effect on Pouch pH of Esomeprazole After Gastric Bypass
Obesity, Gastric Reflux
Recruiting
The Transit Bipartition With the Use of a Metallic Anastomosis Clip and Circular Fundocorporeal Gastroplication
Type 2 Diabetes Mellitus (T2DM), Obesity & Overweight
RecruitingPhase 1
Compare and Evaluate the Safety and PK Data of a Single Dose Administration of 'AD-115A' or 'AD-1151'
Gastric Ulcer

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.

Study Director study director

Takeda

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Gastric or Duodenal Ulcers, run by Takeda 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 4 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: finished, as of the sponsor's last update on 11 Mar 2020. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Had One or More Adverse Drug Reactions (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03214094.

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 11 Mar 2020.