A History of Gastric or Duodenal Ulcers
Conditions
Brief summary
The purpose of this study is to investigate the safety and efficacy of long-term administration of Vonoprazan tablets (Takecab tablets) for up to 12 months in the routine clinical setting in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs).
Detailed description
The drug being tested in this study is called Vonoprazan. Vonoprazan is being tested to treat people who have a history of gastric or duodenal ulcers. This study will look at the safety and efficacy of long-term administration of Vonoprazan tablets for up to 12 months in the routine clinical setting in patients receiving NSAIDs. The study will enroll approximately 1000 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 haemorrhage at initiation of vonoprazan therapy * Participants with a history of hypersensitivity to any ingredients of 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 | Up to 12 months | The presence or absence of onset of gastric ulcers was reported. Reporting data was total percentage of participants with gastric ulcers. |
| Percentage of Participants With Duodenal Ulcers | Up to 12 months | The presence or absence of onset of duodenal ulcers was reported. Reporting data was total percentage of participants with duodenal ulcers. |
| Percentage of Participants With Gastric Hemorrhagic Lesions | Up to 12 months | The presence or absence of onset of gastric hemorrhagic lesions was reported. Reporting data was total percentage of participants with gastric hemorrhagic lesions. |
| Percentage of Participants With Duodenal Hemorrhagic Lesions | Up to 12 months | The presence or absence of onset of duodenal hemorrhagic lesions was reported. Reporting data was total percentage of participants with duodenal hemorrhagic lesions. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the survey at 145 investigative sites in Japan, from 01 September 2016 to 30 April 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. | 1,268 |
| Total | 1,268 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Case Report Forms Uncollected | 18 |
| Overall Study | Protocol Deviation | 18 |
Baseline characteristics
| Characteristic | Vonoprazan 10 mg | — |
|---|---|---|
| Age, Continuous | 70.9 Years STANDARD_DEVIATION 13.46 | — |
| BMI | 23.79 Kilogram (kg)/meter (m)^2 STANDARD_DEVIATION 4.055 | — |
| Drinking Habits Current Drinker | 154 Participants | — |
| Drinking Habits Never Drank or Ex Drinker | 848 Participants | — |
| Drinking Habits Unknown | 266 Participants | — |
| Healthcare Category Inpatient | 35 Participants | — |
| Healthcare Category Outpatient | 1233 Participants | — |
| Height | 155.63 Centimeters (cm) STANDARD_DEVIATION 9.603 | — |
| Helicobacter Pylori Infection Negative | 474 Participants | — |
| Helicobacter Pylori Infection Positive | 24 Participants | — |
| Helicobacter Pylori Infection Unknown | 770 Participants | — |
| Medical Complications Had Medical Complications | 929 Participants | — |
| Medical Complications Had No Medical Complications | 339 Participants | — |
| Medical History (Duodenal Ulcer) | 154 Participants | — |
| Medical History (Gastric Ulcer) | 1142 Participants | — |
| Predisposition to Hypersensitivity Had No Predisposition to Hypersensitivity | 1052 Participants | — |
| Predisposition to Hypersensitivity Had Predisposition to Hypersensitivity | 60 Participants | — |
| Predisposition to Hypersensitivity Unknown | 156 Participants | — |
| Presence of Stress as a Risk Factor of Gastric or Duodenal Ulcer Absent | 670 Participants | — |
| Presence of Stress as a Risk Factor of Gastric or Duodenal Ulcer Present | 162 Participants | — |
| Presence of Stress as a Risk Factor of Gastric or Duodenal Ulcer Unknown | 436 Participants | — |
| Prior Treatment with Acid Suppressants to Prevent Recurrent Gastric or Duodenal Ulcer Had No Prior Treatment with Acid Suppressants | 661 Participants | — |
| Prior Treatment with Acid Suppressants to Prevent Recurrent Gastric or Duodenal Ulcer Had Prior Treatment with Acid Suppressants | 505 Participants | — |
| Prior Treatment with Acid Suppressants to Prevent Recurrent Gastric or Duodenal Ulcer Unknown | 102 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Reason for Use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) , Osteoarthritis | 879 Participants | — |
| Reason for Use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) , Others | 259 Participants | — |
| Reason for Use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), Rheumatoid Arthritis | 168 Participants | — |
| Region of Enrollment Japan | 1268 Participants | — |
| Sex: Female, Male Female | 839 Participants | — |
| Sex: Female, Male Male | 429 Participants | — |
| Smoking Classification Current Smoker | 108 Participants | — |
| Smoking Classification Ex-Smoker | 236 Participants | — |
| Smoking Classification Never Smoked | 627 Participants | — |
| Smoking Classification Unknown | 297 Participants | — |
| Weight | 57.91 Kilograms (kg) STANDARD_DEVIATION 12.48 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 1,268 |
| other Total, other adverse events | 21 / 1,268 |
| serious Total, serious adverse events | 17 / 1,268 |
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 | 0.71 Percentage of Participants |
Secondary
Percentage of Participants With Duodenal Hemorrhagic Lesions
The presence or absence of onset of duodenal hemorrhagic lesions was reported. Reporting data was total percentage of participants with duodenal hemorrhagic lesions.
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 Hemorrhagic Lesions | 0.08 Percentage of Participants |
Secondary
Percentage of Participants With Duodenal Ulcers
The presence or absence of onset of duodenal ulcers was reported. Reporting data was total percentage of participants with duodenal ulcers.
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 | 0.16 Percentage of Participants |
Secondary
Percentage of Participants With Gastric Hemorrhagic Lesions
The presence or absence of onset of gastric hemorrhagic lesions was reported. Reporting data was total percentage of participants with gastric hemorrhagic lesions.
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 Hemorrhagic Lesions | 0.24 Percentage of Participants |
Secondary
Percentage of Participants With Gastric Ulcers
The presence or absence of onset of gastric ulcers was reported. Reporting data was total percentage of participants with gastric ulcers.
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 | 0.56 Percentage of Participants |