Trial Outcomes & Findings for Drug Use Surveillance of Takecab for "Supplement to Helicobacter Pylori Eradication" (NCT NCT03219723)
NCT ID: NCT03219723
Last Updated: 2019-03-22
Results Overview
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).
Recruitment status
COMPLETED
Target enrollment
560 participants
Primary outcome timeframe
Up to 7 days and 2 months
Results posted on
2019-03-22
Participant Flow
Participants took part in the study at 58 investigative sites in Japan, from 01 September 2015 to 30 April 2017.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
560
|
|
Overall Study
COMPLETED
|
550
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
|
Overall Study
Case Report Forms Uncollected
|
6
|
|
Overall Study
Protocol Deviation
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Vonoprazan 20 mg
n=550 Participants
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.
|
|---|---|
|
Age, Continuous
|
58.7 Years
STANDARD_DEVIATION 13.27 • n=550 Participants
|
|
Sex: Female, Male
Female
|
293 Participants
n=550 Participants
|
|
Sex: Female, Male
Male
|
257 Participants
n=550 Participants
|
|
Region of Enrollment
Japan
|
550 Participants
n=550 Participants
|
|
Trial Indications
Gastric Ulcer
|
50 Participants
n=550 Participants
|
|
Trial Indications
Duodenal Ulcer
|
31 Participants
n=550 Participants
|
|
Trial Indications
Idiopathic Thrombocytopenic Purpura
|
12 Participants
n=550 Participants
|
|
Trial Indications
Stomach Following Endoscopic Treatment of EGC
|
12 Participants
n=550 Participants
|
|
Trial Indications
H. Pylori Gastritis
|
476 Participants
n=550 Participants
|
|
Healthcare Category
Outpatient
|
546 Participants
n=550 Participants
|
|
Healthcare Category
Inpatient
|
4 Participants
n=550 Participants
|
|
Predisposition to Hypersensitivity
Had Predisposition to Hypersensitivity
|
16 Participants
n=550 Participants
|
|
Predisposition to Hypersensitivity
Had No Predisposition to Hypersensitivity
|
518 Participants
n=550 Participants
|
|
Predisposition to Hypersensitivity
Unknown
|
16 Participants
n=550 Participants
|
|
Medical Complications
Had Presence of Medical Complications
|
232 Participants
n=550 Participants
|
|
Medical Complications
Had No Presence of Medical Complications
|
318 Participants
n=550 Participants
|
|
Pre-Therapy of H. Pylori Eradication before Study
PPI + AMPC + CAM 400 mg
|
7 Participants
n=48 Participants • Reported data was the number of participants who H. pylori eradication has been unsuccessful in pre-treatment by Vonoprazan or PPI, AMPC and CAM before this study (totally 48 participants).
|
|
Pre-Therapy of H. Pylori Eradication before Study
PPI + AMPC + CAM 800 mg
|
27 Participants
n=48 Participants • Reported data was the number of participants who H. pylori eradication has been unsuccessful in pre-treatment by Vonoprazan or PPI, AMPC and CAM before this study (totally 48 participants).
|
|
Pre-Therapy of H. Pylori Eradication before Study
Vonoprazan + AMPC + CAM 400 mg
|
4 Participants
n=48 Participants • Reported data was the number of participants who H. pylori eradication has been unsuccessful in pre-treatment by Vonoprazan or PPI, AMPC and CAM before this study (totally 48 participants).
|
|
Pre-Therapy of H. Pylori Eradication before Study
Vonoprazan + AMPC + CAM 800 mg
|
7 Participants
n=48 Participants • Reported data was the number of participants who H. pylori eradication has been unsuccessful in pre-treatment by Vonoprazan or PPI, AMPC and CAM before this study (totally 48 participants).
|
|
Pre-Therapy of H. Pylori Eradication before Study
Unknown
|
3 Participants
n=48 Participants • Reported data was the number of participants who H. pylori eradication has been unsuccessful in pre-treatment by Vonoprazan or PPI, AMPC and CAM before this study (totally 48 participants).
|
|
Height
|
160.62 Centimeters (cm)
STANDARD_DEVIATION 9.148 • n=306 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Weight
|
59.63 Kilograms (kg)
STANDARD_DEVIATION 11.377 • n=318 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
BMI
|
23.03 kg/m^2
STANDARD_DEVIATION 3.481 • n=304 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Smoking Classification
Never Smoked
|
266 Participants
n=550 Participants
|
|
Smoking Classification
Current Smoker
|
67 Participants
n=550 Participants
|
|
Smoking Classification
Ex-Smoker
|
68 Participants
n=550 Participants
|
|
Smoking Classification
Unknown
|
149 Participants
n=550 Participants
|
|
Drinking Habits
Yes
|
118 Participants
n=550 Participants
|
|
Drinking Habits
No
|
302 Participants
n=550 Participants
|
|
Drinking Habits
Unknown
|
130 Participants
n=550 Participants
|
|
Diagnostic Test for H. Pylori Infection
Rapid Urease Test
|
103 Participants
n=550 Participants
|
|
Diagnostic Test for H. Pylori Infection
Microscopy
|
43 Participants
n=550 Participants
|
|
Diagnostic Test for H. Pylori Infection
Culture Method
|
26 Participants
n=550 Participants
|
|
Diagnostic Test for H. Pylori Infection
Urea Breath Test
|
167 Participants
n=550 Participants
|
|
Diagnostic Test for H. Pylori Infection
Anti-H. Pylori Antibody Test
|
209 Participants
n=550 Participants
|
|
Diagnostic Test for H. Pylori Infection
Stool H. Pylori Antigen Test
|
12 Participants
n=550 Participants
|
|
Treatment
First-Line Eradication
|
502 Participants
n=550 Participants
|
|
Treatment
Second-Line Eradication
|
48 Participants
n=550 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days and 2 monthsPopulation: Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.
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).
Outcome measures
| Measure |
Vonoprazan 20 mg
n=550 Participants
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.
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|---|---|
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Percentage of Participants Who Had One or More Adverse Drug Reactions
|
3.09 Percentage of Participants
|
SECONDARY outcome
Timeframe: 7 days + 2 monthsPopulation: 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.
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).
Outcome measures
| Measure |
Vonoprazan 20 mg
n=550 Participants
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.
|
|---|---|
|
H. Pylori Eradication Rate
First-Line Eradication
|
91.24 Percent
Interval 88.3 to 93.64
|
|
H. Pylori Eradication Rate
Second-Line Eradication
|
95.45 Percent
Interval 84.53 to 99.44
|
Adverse Events
Vonoprazan 20 mg
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vonoprazan 20 mg
n=550 participants at risk
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.
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|---|---|
|
Infections and infestations
Influenza
|
0.18%
1/550 • Up to 7days and 2 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
0.18%
1/550 • Up to 7days and 2 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dysgeusia
|
0.55%
3/550 • Up to 7days and 2 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Hypogeusia
|
0.18%
1/550 • Up to 7days and 2 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.18%
1/550 • Up to 7days and 2 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.18%
1/550 • Up to 7days and 2 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.18%
1/550 • Up to 7days and 2 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.73%
4/550 • Up to 7days and 2 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Faeces hard
|
0.18%
1/550 • Up to 7days and 2 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Ileus
|
0.18%
1/550 • Up to 7days and 2 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.91%
5/550 • Up to 7days and 2 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.18%
1/550 • Up to 7days and 2 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.18%
1/550 • Up to 7days and 2 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Faeces soft
|
0.36%
2/550 • Up to 7days and 2 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Liver disorder
|
0.18%
1/550 • Up to 7days and 2 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.36%
2/550 • Up to 7days and 2 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.18%
1/550 • Up to 7days and 2 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.36%
2/550 • Up to 7days and 2 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.18%
1/550 • Up to 7days and 2 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Malaise
|
0.18%
1/550 • Up to 7days and 2 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER