Gastric/Duodenal Ulcer, Gastric MALT Lymphoma, Idiopathic Thrombocytopenic Purpura, or H. Pylori Gastritis, and Other
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy on participants receiving first-line eradication and second-line eradication including vonoprazan (Takecab) tablets (triple therapy) in the routine clinical setting.
Detailed description
The drug being tested in this study is called Vonoprazan (Takecab). Vonoprazan is being tested to treat people who have gastric ulcer, duodenal ulcer, gastric mucosa-associated lymphoid tissue (MALT) lymphoma, idiopathic thrombocytopenic purpura, stomach following endoscopic treatment of early gastric cancer, or H. pylori gastritis. This study will look at the presence or absence of new concerns regarding the safety of triple therapy with Vonoprazan tablets, amoxicillin, and clarithromycin (first-line eradication) and triple therapy with Vonoprazan tablets, amoxicillin, and metronidazole (second-line eradication) for supplemental Helicobacter pylori (H. pylori) eradication in the routine clinical setting. The study will enroll approximately 500 patients. First-line eradication * Vonoprazan 20 mg / Proton pump inhibitor * Amoxicillin hydrate 750 mg * Clarithromycin 200 mg If H. pylori eradication with a three-drug regimen comprising vonoprazan or proton pump inhibitor + amoxicillin hydrate + clarithromycin has been unsuccessful. Second-line eradication * Vonoprazan 20 mg * Amoxicillin hydrate 750 mg * metronidazole 250 mg This multi-center trial will be conducted in Japan.
Interventions
DRUGVonoprazan
Vonoprazan tablets
DRUGAmoxicillin hydrate
Amoxicillin hydrate (potency)
DRUGClarithromycin
Clarithromycin (potency)
DRUGMetronidazole
Metronidazole
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Participants receiving H. pylori eradication treatment for the first time * Participants for whom H. pylori eradication with Takecab tablets or proton pump inhibitor + amoxicillin + clarithromycin was found unsuccessful and who will receive eradication treatment with amoxicillin and metronidazole
Exclusion criteria
* Participants with previous history of hypersensitivity to ingredients in Takecab tablets * Participants taking 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 7 days and 2 months | Adverse drug reaction refers to adverse events related to administered drug. Timeframe was defined as duration of triple therapy (7 days) and up to the time of determination of H. pylori eradication after triple therapy (approximately 2 months as maximum duration). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| H. Pylori Eradication Rate | 7 days + 2 months | In participants who were determined as achieving H. pylori eradication, the percentage of participants negative for H. pylori (eradication rates) was tabulated by first-line eradication and second-line eradication. Timeframe was defined as duration of triple therapy (7 days) and up to the time of determination of H. pylori eradication after triple therapy (approximately 2 months as maximum duration). |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at 58 investigative sites in Japan, from 01 September 2015 to 30 April 2017.
Pre-assignment details
Participants with a historical diagnosis of gastric/duodenal ulcer, idiopathic thrombocytopenic purpura, stomach following endoscopic treatment of early gastric cancer, or H. pylori gastritis were enrolled to receive interventions as part of routine medical care. However, participants with gastric MALT lymphoma were not enrolled in the survey.
Participants by arm
| Arm | Count |
|---|---|
| Vonoprazan 20 mg For adults, the following three-drug regimen was administered orally at the same time twice daily for 7 days: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 200 mg (potency) dose of clarithromycin. The dose of clarithromycin allowed to be increased as clinically warranted. However, dosage was not to exceed 400 mg (potency)/ dose twice daily. If H. pylori eradication with a three-drug regimen comprising vonoprazan or proton pump inhibitor + amoxicillin hydrate + clarithromycin had been unsuccessful, as an alternative treatment, the following three-drug regimen was administered orally twice daily for 7 days to adults: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 250 mg dose of metronidazole. Participants received interventions as part of routine medical care. | 550 |
| Total | 550 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Case Report Forms Uncollected | 6 |
| Overall Study | Protocol Deviation | 4 |
Baseline characteristics
| Characteristic | Vonoprazan 20 mg | — |
|---|---|---|
| Age, Continuous | 58.7 Years STANDARD_DEVIATION 13.27 | — |
| BMI | 23.03 kg/m^2 STANDARD_DEVIATION 3.481 | — |
| Diagnostic Test for H. Pylori Infection Anti-H. Pylori Antibody Test | 209 Participants | — |
| Diagnostic Test for H. Pylori Infection Culture Method | 26 Participants | — |
| Diagnostic Test for H. Pylori Infection Microscopy | 43 Participants | — |
| Diagnostic Test for H. Pylori Infection Rapid Urease Test | 103 Participants | — |
| Diagnostic Test for H. Pylori Infection Stool H. Pylori Antigen Test | 12 Participants | — |
| Diagnostic Test for H. Pylori Infection Urea Breath Test | 167 Participants | — |
| Drinking Habits No | 302 Participants | — |
| Drinking Habits Unknown | 130 Participants | — |
| Drinking Habits Yes | 118 Participants | — |
| Healthcare Category Inpatient | 4 Participants | — |
| Healthcare Category Outpatient | 546 Participants | — |
| Height | 160.62 Centimeters (cm) STANDARD_DEVIATION 9.148 | — |
| Medical Complications Had No Presence of Medical Complications | 318 Participants | — |
| Medical Complications Had Presence of Medical Complications | 232 Participants | — |
| Predisposition to Hypersensitivity Had No Predisposition to Hypersensitivity | 518 Participants | — |
| Predisposition to Hypersensitivity Had Predisposition to Hypersensitivity | 16 Participants | — |
| Predisposition to Hypersensitivity Unknown | 16 Participants | — |
| Pre-Therapy of H. Pylori Eradication before Study PPI + AMPC + CAM 400 mg | 7 Participants | — |
| Pre-Therapy of H. Pylori Eradication before Study PPI + AMPC + CAM 800 mg | 27 Participants | — |
| Pre-Therapy of H. Pylori Eradication before Study Unknown | 3 Participants | — |
| Pre-Therapy of H. Pylori Eradication before Study Vonoprazan + AMPC + CAM 400 mg | 4 Participants | — |
| Pre-Therapy of H. Pylori Eradication before Study Vonoprazan + AMPC + CAM 800 mg | 7 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Japan | 550 Participants | — |
| Sex: Female, Male Female | 293 Participants | — |
| Sex: Female, Male Male | 257 Participants | — |
| Smoking Classification Current Smoker | 67 Participants | — |
| Smoking Classification Ex-Smoker | 68 Participants | — |
| Smoking Classification Never Smoked | 266 Participants | — |
| Smoking Classification Unknown | 149 Participants | — |
| Treatment First-Line Eradication | 502 Participants | — |
| Treatment Second-Line Eradication | 48 Participants | — |
| Trial Indications Duodenal Ulcer | 31 Participants | — |
| Trial Indications Gastric Ulcer | 50 Participants | — |
| Trial Indications H. Pylori Gastritis | 476 Participants | — |
| Trial Indications Idiopathic Thrombocytopenic Purpura | 12 Participants | — |
| Trial Indications Stomach Following Endoscopic Treatment of EGC | 12 Participants | — |
| Weight | 59.63 Kilograms (kg) STANDARD_DEVIATION 11.377 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 550 |
| other Total, other adverse events | 22 / 550 |
| serious Total, serious adverse events | 0 / 550 |
Outcome results
Primary
Percentage of Participants Who Had One or More Adverse Drug Reactions
Adverse drug reaction refers to adverse events related to administered drug. Timeframe was defined as duration of triple therapy (7 days) and up to the time of determination of H. pylori eradication after triple therapy (approximately 2 months as maximum duration).
Time frame: Up to 7 days and 2 months
Population: Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vonoprazan 20 mg | Percentage of Participants Who Had One or More Adverse Drug Reactions | 3.09 Percentage of Participants |
Secondary
H. Pylori Eradication Rate
In participants who were determined as achieving H. pylori eradication, the percentage of participants negative for H. pylori (eradication rates) was tabulated by first-line eradication and second-line eradication. Timeframe was defined as duration of triple therapy (7 days) and up to the time of determination of H. pylori eradication after triple therapy (approximately 2 months as maximum duration).
Time frame: 7 days + 2 months
Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vonoprazan 20 mg | H. Pylori Eradication Rate | Second-Line Eradication | 95.45 Percent |
| Vonoprazan 20 mg | H. Pylori Eradication Rate | First-Line Eradication | 91.24 Percent |