Gastric Ulcer, Duodenal Ulcer, and Reflux EsophagitisNCT03214952
Drug Use Surveillance of Vonoprazan for "Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis"
An observational study of Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis, run by Takeda at 1 site in Japan.
Trial summary
The purpose of this survey is to evaluate the safety and effectiveness of vonoprazan tablets in patients with gastric ulcer, duodenal ulcer, and reflux esophagitis in the routine clinical setting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis
- What is being tested?
- Vonoprazan
- Type of treatment
- Pill or oral medicine
- How many people
- 3,183 participants
- Where
- 1 siteJapan
- Study dates
- 1 Mar 2016to 31 Oct 2018
- 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 study population will consist of participants with a diagnosis of gastric ulcer, duodenal ulcer, and reflux esophagitis and receive Vonoprazan in the routine clinical setting.
Who may be able to join
- Participants with gastric ulcer, duodenal ulcer, and reflux esophagitis
Who cannot join
- Participants with previous history of hypersensitivity to ingredients in Takecab tablets
- Participants taking atazanavir sulfate or rilpivirine hydrochloride
- Participants meeting the criteria of scarring stage (S1, S2) of endoscopic classification defined by Sakita and Miwa at the start of the treatment with Takecab tablets, in the case that the target disease is gastric ulcer or duodenal ulcer
- Participants meeting the criteria of Grade N or Grade M of Los Angeles classification (Hoshihara's modification) at the start of the treatment with Takecab tablets, in the case that the target disease is reflux esophagitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug Use Surveillance of Takecab Tablets for "Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis"
The purpose of this survey is to evaluate the safety and effectiveness of vonoprazan tablets in patients with gastric ulcer, duodenal ulcer, and reflux esophagitis in the routine clinical setting.
Read the detailed description
The drug being tested in this survey is called vonoprazan. Vonoprazan is being tested to treat patients who have gastric ulcer, duodenal ulcer, and reflux esophagitis.
This survey will look at the safety and effectiveness of vonoprazan in patients with gastric ulcer, duodenal ulcer, and reflux esophagitis in the routine clinical setting. The survey will enroll approximately 3000 participants.
- Vonoprazan 20 mg
This multi-center survey will be conducted in Japan.
- Being tested
- Vonoprazan
- Medical subject headings
- Stomach Ulcer, Duodenal Ulcer, Esophagitis, Peptic
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 group | Role | What they receive |
|---|---|---|
| Vonoprazan 20 mg | The usual adult dosage for oral use is 20 mg of vonoprazan administered orally once daily. An 8-week treatment for gastric ulcer and a 6-week treatment for duodenal ulcer. For reflux esophagitis, the usual adult dosage for oral use was administered for a total of 4 weeks of treatment, and if that dosing proved insufficient, the administration may have been extended, but for no longer than 8 weeks of treatment. Participants received vonoprazan as part of a 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 With Gastric Ulcer 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 the administered drug.
Measured: Up to 8 weeks
Percentage of Participants With Duodenal Ulcer Who Had One or More Adverse Drug Reactions
An 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 the administered drug.
Measured: Up to 6 weeks
Percentage of Participants With Reflux Esophagitis Who Had One or More Adverse Drug Reactions
An 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 the administered drug.
Measured: Up to 8 weeks
Secondary outcomes (6)
Endoscopic Cure Rate in Participants With Gastric Ulcer
Endoscopic cure rate was defined as a percentage of participants treated for gastric ulcer who classified as Scarring stage at the end of survey per Sakita-Miwa Classification. Endoscopic findings of ulcer were classified per Sakita-Miwa Classification as follows; Active stage: A1 and A2, Healing stage: H1 and H2, Scarring stage: S1 and S2.
Measured: Up to 8 weeks
Endoscopic Cure Rate in Participants With Duodenal Ulcer
Endoscopic cure rate was defined as a percentage of participants treated for duodenal ulcer who classified as Scarring stage at the end of survey per Sakita-Miwa Classification. Endoscopic findings of ulcer were classified per Sakita-Miwa Classification as follows; Active stage: A1 and A2, Healing stage: H1 and H2, Scarring stage: S1 and S2.
Measured: Up to 6 weeks
Endoscopic Cure Rate in Participants With Reflux Esophagitis
Endoscopic cure rate was defined as a percentage of participants who treated for reflux esophagitis and met the criteria of Grade N or M in the modified Los Angeles (LA) classification at the end of survey. Grade N: normal mucosa; Grade M: minimal changes to the mucosa, such as erythema and/or whitish turbidity.
Measured: Up to 8 weeks
Percentage of Participants With Gastric Ulcer Whose Subjective Symptoms Improved
Percentage of participants who treated for gastric ulcer and whose subjective symptoms, including heartburn, acid reflux, postprandial fullness, early satiation, epigastric pain, epigastric burning, abdominal bloating, nausea/vomiting, belching and anorexia, were improved was reported. Presence or absence and severity of subjective symptoms were graded as asymptomatic, mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), and severe (unendurably symptomatic). Participants with whose subjective symptom was improved by one grade or better were defined as "Improved".
Measured: Baseline and at the end of the survey (up to 8 weeks)
Percentage of Participants With Duodenal Ulcer Whose Subjective Symptoms Improved
Percentage of participants who treated for duodenal ulcer and whose subjective symptoms, including heartburn, acid reflux, postprandial fullness, early satiation, epigastric pain, epigastric burning, abdominal bloating, nausea/vomiting, belching and anorexia, were improved was reported. Presence or absence and severity of subjective symptoms were graded as asymptomatic, mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), and severe (unendurably symptomatic). Participants with whose subjective symptom was improved by one grade or better were defined as "Improved".
Measured: Baseline and at the end of the survey (up to 6 weeks)
Percentage of Participants With Reflux Esophagitis Whose Subjective Symptoms Improved
Percentage of participants who treated for reflux esophagitis and whose subjective symptoms, including heartburn, acid reflux, postprandial fullness, early satiation, epigastric pain, epigastric burning, abdominal bloating, nausea/vomiting, belching and anorexia, were improved was reported. Presence or absence and severity of subjective symptoms were graded as asymptomatic, mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), and severe (unendurably symptomatic). Participants with whose subjective symptom was improved by one grade or better were defined as "Improved".
Measured: Baseline and at the end of the survey (up to 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start1 Mar 2016
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
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 Ulcer, Duodenal Ulcer, and Reflux EsophagitisStudies 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
- 3,183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214952
- Sponsor's protocol ID
- Vonoprazan-5001
- Other IDs
- JapicCTI-163177
- Status last verified
- Nov 2019
- First submitted
- 9 Jul 2017
- Last updated
- 12 Dec 2019
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use Surveillance of Takecab Tablets for "Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis"
- ClinicalTrials.gov ID
- NCT03214952
- Acronym / sponsor ID
- Vonoprazan-5001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,183 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 12 Jul 2017 (actual)
- Results
- Posted 12 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this survey is to evaluate the safety and effectiveness of vonoprazan tablets in patients with gastric ulcer, duodenal ulcer, and reflux esophagitis in the routine clinical setting.
Detailed description
The drug being tested in this survey is called vonoprazan. Vonoprazan is being tested to treat patients who have gastric ulcer, duodenal ulcer, and reflux esophagitis.
This survey will look at the safety and effectiveness of vonoprazan in patients with gastric ulcer, duodenal ulcer, and reflux esophagitis in the routine clinical setting. The survey will enroll approximately 3000 participants.
- Vonoprazan 20 mg
This multi-center survey will be conducted in Japan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vonoprazan 20 mg | – | Drug: VonoprazanThe usual adult dosage for oral use is 20 mg of vonoprazan administered orally once daily. An 8-week treatment for gastric ulcer and a 6-week treatment for duodenal ulcer. For reflux esophagitis, the usual adult dosage for oral use was administered for a total of 4 weeks of treatment, and if that dosing proved insufficient, the administration may have been extended, but for no longer than 8 weeks of treatment. Participants received vonoprazan as part of a routine medical care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of participants with a diagnosis of gastric ulcer, duodenal ulcer, and reflux esophagitis and receive Vonoprazan in the routine clinical setting.
Key inclusion criteria (1 listed)
- Participants with gastric ulcer, duodenal ulcer, and reflux esophagitis
Key exclusion criteria (4 listed)
- Participants with previous history of hypersensitivity to ingredients in Takecab tablets
- Participants taking atazanavir sulfate or rilpivirine hydrochloride
- Participants meeting the criteria of scarring stage (S1, S2) of endoscopic classification defined by Sakita and Miwa at the start of the treatment with Takecab tablets, in the case that the target disease is gastric ulcer or duodenal ulcer
- Participants meeting the criteria of Grade N or Grade M of Los Angeles classification (Hoshihara's modification) at the start of the treatment with Takecab tablets, in the case that the target disease is reflux esophagitis.
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 20 mg |
Primary outcome
Percentage of Participants With Gastric Ulcer Who Had One or More Adverse Drug Reactions
Time frame: Up to 8 weeks
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 the administered drug.
Percentage of Participants With Duodenal Ulcer Who Had One or More Adverse Drug Reactions
Time frame: Up to 6 weeks
An 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 the administered drug.
Percentage of Participants With Reflux Esophagitis Who Had One or More Adverse Drug Reactions
Time frame: Up to 8 weeks
An 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 the administered drug.
6 secondary outcomes
Endoscopic Cure Rate in Participants With Gastric Ulcer
Time frame: Up to 8 weeks
Endoscopic Cure Rate in Participants With Duodenal Ulcer
Time frame: Up to 6 weeks
Endoscopic Cure Rate in Participants With Reflux Esophagitis
Time frame: Up to 8 weeks
Percentage of Participants With Gastric Ulcer Whose Subjective Symptoms Improved
Time frame: Baseline and at the end of the survey (up to 8 weeks)
Percentage of Participants With Duodenal Ulcer Whose Subjective Symptoms Improved
Time frame: Baseline and at the end of the survey (up to 6 weeks)
Percentage of Participants With Reflux Esophagitis Whose Subjective Symptoms Improved
Time frame: Baseline and at the end of the survey (up to 8 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- 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.
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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.
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 Ulcer, Duodenal Ulcer, and Reflux Esophagitis, 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 12 Dec 2019. 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 12 Dec 2019). 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 With Gastric Ulcer Who Had One or More Adverse Drug Reactions (time frame: Up to 8 weeks). The study lists 3 primary outcomes in all. 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 12 Dec 2019.