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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-163435 | Registry Identifier | JapicCTI |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vonoprazan | Drug | Vonoprazan tablets |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 12 months |
| Percentage of Participants With Duodenal Ulcers After the Start of Administration of Vonoprazan Tablets |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Takeda Selected Site | Tokyo | Japan |
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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Participants with a historical diagnosis of gastric or duodenal ulcers were enrolled. Participants received vonoprazan as part of a routine medical care.
Participants took part in the survey at 121 investigative sites in Japan, from 01 September 2016 to 28 February 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Number | Percentage of Participants | Up to 12 months |
|
Up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endocarditis | Infections and infestations | MedDRA Ver. 22.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA Ver. 22.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 2, 2017 | Feb 21, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 7, 2019 | Feb 21, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D004381 | Duodenal Ulcer |
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C552956 | 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine |
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Reported data were percentage of participants who experienced an onset of duodenal ulcers after the start of administration of vonoprazan tablets. |
| 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. | 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. | Up to 12 months |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | All participants were enrolled in Japan | Count of Participants | Participants |
|
| Medical History | Number of participants with or without medical history of Gastric Ulcer or Duodenal Ulcer was reported. | Participants could be counted in more than 1 category (including duplicates). | Count of Participants | Participants |
|
| Purpose of Low-Dose Aspirin Use | Participants could be counted in more than 1 category (including duplicates). | Count of Participants | Participants |
|
| Implantation of Coronary Stent | Count of Participants | Participants |
|
| Healthcare Category | Participants were categorized as outpatient and inpatient. | Count of Participants | Participants |
|
| Predisposition to Hypersensitivity | Number of participants who had or did not have a liability or tendency to suffer from hypersensitivity was reported. | Count of Participants | Participants |
|
| Medical Complications | Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above. | Count of Participants | Participants |
|
| Height | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Centimeters (cm) |
|
| Weight | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Kilograms (kg) |
|
| BMI | Body Mass Index = weight (kg)/[height (m)^2] | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Kilogram (kg)/meter (m)^2 |
|
| Helicobacter Pylori Infection | Number of participants with or without medical history of H. pylori was reported. "Negative" indicates the absence of H. pylori infection, "Positive" indicates presence of the infection. | Count of Participants | Participants |
|
| Smoking Classification | Count of Participants | Participants |
|
| Drinking Habits | Count of Participants | Participants |
|
| Presence of Stress as a Risk Factor of Gastric or Duodenal Ulcer | Count of Participants | Participants |
|
| Prior Treatment with Acid Suppressants to Prevent Recurrent Gastric or Duodenal Ulcer | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | 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. | Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. | Posted | Number | Percentage of Participants | Up to 12 months |
|
|
|
| Secondary | 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. | Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. | Posted | Number | Percentage of Participants | Up to 12 months |
|
|
|
| Secondary | 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. | Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. | Posted | Number | Percentage of Participants | Up to 12 months |
|
|
|
| Secondary | 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. | Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. | Posted | Number | Percentage of Participants | Up to 12 months |
|
|
|
| 9 |
| 1,059 |
| 50 |
| 1,059 |
| 4 |
| 1,059 |
| Gangrene | Infections and infestations | MedDRA Ver. 22.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA Ver. 22.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA Ver. 22.0 | Systematic Assessment |
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| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 22.0 | Systematic Assessment |
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| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 22.0 | Systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 22.0 | Systematic Assessment |
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| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 22.0 | Systematic Assessment |
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| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 22.0 | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 22.0 | Systematic Assessment |
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| Carotid artery stenosis | Nervous system disorders | MedDRA Ver. 22.0 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA Ver. 22.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Ver. 22.0 | Systematic Assessment |
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| Motor neurone disease | Nervous system disorders | MedDRA Ver. 22.0 | Systematic Assessment |
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| Myelopathy | Nervous system disorders | MedDRA Ver. 22.0 | Systematic Assessment |
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| Cataract nuclear | Eye disorders | MedDRA Ver. 22.0 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA Ver. 22.0 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA Ver. 22.0 | Systematic Assessment |
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| Atrioventricular block complete | Cardiac disorders | MedDRA Ver. 22.0 | Systematic Assessment |
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| Heart failures | Cardiac disorders | MedDRA Ver. 22.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA Ver. 22.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA Ver. 22.0 | Systematic Assessment |
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| Sinus node dysfunction | Cardiac disorders | MedDRA Ver. 22.0 | Systematic Assessment |
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| Aortic aneurysm | Vascular disorders | MedDRA Ver. 22.0 | Systematic Assessment |
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| Peripheral arterial occlusive disease | Vascular disorders | MedDRA Ver. 22.0 | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 22.0 | Systematic Assessment |
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| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 22.0 | Systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 22.0 | Systematic Assessment |
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| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 22.0 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA Ver. 22.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Ver. 22.0 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA Ver. 22.0 | Systematic Assessment |
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| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Ver. 22.0 | Systematic Assessment |
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| Bile duct stone | Hepatobiliary disorders | MedDRA Ver. 22.0 | Systematic Assessment |
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| Cholangitis | Hepatobiliary disorders | MedDRA Ver. 22.0 | Systematic Assessment |
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| Cholangitis acute | Hepatobiliary disorders | MedDRA Ver. 22.0 | Systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA Ver. 22.0 | Systematic Assessment |
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| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA Ver. 22.0 | Systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA Ver. 22.0 | Systematic Assessment |
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| Vascular complication associated with device | General disorders | MedDRA Ver. 22.0 | Systematic Assessment |
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| Vascular stent stenosis | General disorders | MedDRA Ver. 22.0 | Systematic Assessment |
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| Angiocardiogram | Investigations | MedDRA Ver. 22.0 | Systematic Assessment |
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| Shunt occlusion | Injury, poisoning and procedural complications | MedDRA Ver. 22.0 | Systematic Assessment |
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| Shunt stenosis | Injury, poisoning and procedural complications | MedDRA Ver. 22.0 | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| D004066 |
| Digestive System Diseases |
| D013272 | Stomach Diseases |