Gastric or Duodenal Ulcers
Conditions
Brief 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.
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.
Interventions
DRUGVonoprazan
Vonoprazan tablets
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Participants with a history of gastric or duodenal ulcer
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Had One or More Adverse Drug Reactions | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Gastric Ulcers After the Start of Administration of Vonoprazan Tablets | Up to 12 months | Reported data were percentage of participants who experienced an onset of gastric ulcers after the start of administration of vonoprazan tablets. |
| Percentage of Participants With Duodenal Ulcers After the Start of Administration of Vonoprazan Tablets | Up to 12 months | Reported data were percentage of participants who experienced an onset of duodenal ulcers after the start of administration of vonoprazan tablets. |
| Percentage of Participants With Hemorrhagic Lesions on Stomach After the Start of Administration of Vonoprazan Tablets | Up to 12 months | Reported data were percentage of participants who had hemorrhagic lesions on stomach after the start of administration of vonoprazan tablets. |
| Percentage of Participants With Hemorrhagic Lesions on Duodenum After the Start of Administration of Vonoprazan Tablets | Up to 12 months | Reported data were percentage of participants who had hemorrhagic lesions on duodenum after the start of administration of vonoprazan tablets. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the survey at 121 investigative sites in Japan, from 01 September 2016 to 28 February 2019.
Pre-assignment details
Participants with a historical diagnosis of gastric or duodenal ulcers were enrolled. Participants received vonoprazan as part of a routine medical care.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1,059 |
| Total | 1,059 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Case Report Forms Uncollected | 14 |
| Overall Study | Protocol Deviation | 46 |
Baseline characteristics
| Characteristic | Vonoprazan 10 mg | — |
|---|---|---|
| Age, Continuous | 72.2 Years STANDARD_DEVIATION 10.63 | — |
| BMI | 23.96 Kilogram (kg)/meter (m)^2 STANDARD_DEVIATION 3.71 | — |
| Drinking Habits Current Drinker | 226 Participants | — |
| Drinking Habits Never Drank or Ex Drinker | 537 Participants | — |
| Drinking Habits Unknown | 296 Participants | — |
| Healthcare Category Inpatient | 364 Participants | — |
| Healthcare Category Outpatient | 695 Participants | — |
| Height | 160.52 Centimeters (cm) STANDARD_DEVIATION 9.361 | — |
| Helicobacter Pylori Infection Helicobacter Pylori Negative | 107 Participants | — |
| Helicobacter Pylori Infection Helicobacter Pylori Positive | 16 Participants | — |
| Helicobacter Pylori Infection Unknown | 936 Participants | — |
| Implantation of Coronary Stent Implanted | 484 Participants | — |
| Implantation of Coronary Stent Not Implanted | 575 Participants | — |
| Medical Complications Had Medical Complications | 971 Participants | — |
| Medical Complications Had No Medical Complications | 88 Participants | — |
| Medical History Duodenal Ulcer | 121 Participants | — |
| Medical History Gastric Ulcer | 946 Participants | — |
| Predisposition to Hypersensitivity Had No Predisposition to Hypersensitivity | 918 Participants | — |
| Predisposition to Hypersensitivity Had Predisposition to Hypersensitivity | 67 Participants | — |
| Predisposition to Hypersensitivity Unknown | 74 Participants | — |
| Presence of Stress as a Risk Factor of Gastric or Duodenal Ulcer Absent | 381 Participants | — |
| Presence of Stress as a Risk Factor of Gastric or Duodenal Ulcer Present | 117 Participants | — |
| Presence of Stress as a Risk Factor of Gastric or Duodenal Ulcer Unknown | 561 Participants | — |
| Prior Treatment with Acid Suppressants to Prevent Recurrent Gastric or Duodenal Ulcer Had No Prior Treatment with Acid Suppressants | 529 Participants | — |
| Prior Treatment with Acid Suppressants to Prevent Recurrent Gastric or Duodenal Ulcer Had Prior Treatment with Acid Suppressants | 507 Participants | — |
| Prior Treatment with Acid Suppressants to Prevent Recurrent Gastric or Duodenal Ulcer Unknown | 23 Participants | — |
| Purpose of Low-Dose Aspirin Use Angina Pectoris | 464 Participants | — |
| Purpose of Low-Dose Aspirin Use Cerebral Infarction | 294 Participants | — |
| Purpose of Low-Dose Aspirin Use Myocardial Infarction | 278 Participants | — |
| Purpose of Low-Dose Aspirin Use Others | 140 Participants | — |
| Purpose of Low-Dose Aspirin Use Transient Ischaemic Attack (TIA) Population | 27 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Japan | 1059 Participants | — |
| Sex: Female, Male Female | 309 Participants | — |
| Sex: Female, Male Male | 750 Participants | — |
| Smoking Classification Current Smoker | 136 Participants | — |
| Smoking Classification Ex-Smoker | 394 Participants | — |
| Smoking Classification Never Smoked | 324 Participants | — |
| Smoking Classification Unknown | 205 Participants | — |
| Weight | 61.92 Kilograms (kg) STANDARD_DEVIATION 12.591 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 9 / 1,059 |
| other Total, other adverse events | 4 / 1,059 |
| serious Total, serious adverse events | 50 / 1,059 |
Outcome results
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.
Time frame: Up to 12 months
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vonoprazan 10 mg | Percentage of Participants Who Had One or More Adverse Drug Reactions | 1.79 Percentage of Participants |
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.
Time frame: Up to 12 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vonoprazan 10 mg | Percentage of Participants With Duodenal Ulcers After the Start of Administration of Vonoprazan Tablets | 0.19 Percentage of 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.
Time frame: Up to 12 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vonoprazan 10 mg | Percentage of Participants With Gastric Ulcers After the Start of Administration of Vonoprazan Tablets | 0.67 Percentage of Participants |
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.
Time frame: Up to 12 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vonoprazan 10 mg | Percentage of Participants With Hemorrhagic Lesions on Duodenum After the Start of Administration of Vonoprazan Tablets | 0.00 Percentage of Participants |
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.
Time frame: Up to 12 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vonoprazan 10 mg | Percentage of Participants With Hemorrhagic Lesions on Stomach After the Start of Administration of Vonoprazan Tablets | 0.19 Percentage of Participants |