Trial Outcomes & Findings for Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs: Long-term Use" (NCT NCT03214198)
NCT ID: NCT03214198
Last Updated: 2023-06-07
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
1304 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2023-06-07
Participant Flow
Participants took part in the survey at 145 investigative sites in Japan, from 01 September 2016 to 30 April 2019.
Participants with a historical diagnosis of gastric or duodenal ulcers were enrolled. Participants received vonoprazan as part of a routine medical care.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
1304
|
|
Overall Study
COMPLETED
|
1268
|
|
Overall Study
NOT COMPLETED
|
36
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Case Report Forms Uncollected
|
18
|
|
Overall Study
Protocol Deviation
|
18
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Vonoprazan 10 mg
n=1268 Participants
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.
|
|---|---|
|
Age, Continuous
|
70.9 Years
STANDARD_DEVIATION 13.46 • n=1268 Participants
|
|
Sex: Female, Male
Female
|
839 Participants
n=1268 Participants
|
|
Sex: Female, Male
Male
|
429 Participants
n=1268 Participants
|
|
Region of Enrollment
Japan
|
1268 Participants
n=1268 Participants
|
|
Medical History (Gastric Ulcer)
|
1142 Participants
n=1268 Participants
|
|
Medical History (Duodenal Ulcer)
|
154 Participants
n=1268 Participants
|
|
Reason for Use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), Rheumatoid Arthritis
|
168 Participants
n=1268 Participants
|
|
Reason for Use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) , Osteoarthritis
|
879 Participants
n=1268 Participants
|
|
Reason for Use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) , Others
|
259 Participants
n=1268 Participants
|
|
Healthcare Category
Outpatient
|
1233 Participants
n=1268 Participants
|
|
Healthcare Category
Inpatient
|
35 Participants
n=1268 Participants
|
|
Predisposition to Hypersensitivity
Had Predisposition to Hypersensitivity
|
60 Participants
n=1268 Participants
|
|
Predisposition to Hypersensitivity
Had No Predisposition to Hypersensitivity
|
1052 Participants
n=1268 Participants
|
|
Predisposition to Hypersensitivity
Unknown
|
156 Participants
n=1268 Participants
|
|
Medical Complications
Had Medical Complications
|
929 Participants
n=1268 Participants
|
|
Medical Complications
Had No Medical Complications
|
339 Participants
n=1268 Participants
|
|
Height
|
155.63 Centimeters (cm)
STANDARD_DEVIATION 9.603 • n=722 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Weight
|
57.91 Kilograms (kg)
STANDARD_DEVIATION 12.480 • n=727 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
BMI
|
23.79 Kilogram (kg)/meter (m)^2
STANDARD_DEVIATION 4.055 • n=718 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Helicobacter Pylori Infection
Positive
|
24 Participants
n=1268 Participants
|
|
Helicobacter Pylori Infection
Negative
|
474 Participants
n=1268 Participants
|
|
Helicobacter Pylori Infection
Unknown
|
770 Participants
n=1268 Participants
|
|
Smoking Classification
Never Smoked
|
627 Participants
n=1268 Participants
|
|
Smoking Classification
Current Smoker
|
108 Participants
n=1268 Participants
|
|
Smoking Classification
Ex-Smoker
|
236 Participants
n=1268 Participants
|
|
Smoking Classification
Unknown
|
297 Participants
n=1268 Participants
|
|
Drinking Habits
Current Drinker
|
154 Participants
n=1268 Participants
|
|
Drinking Habits
Never Drank or Ex Drinker
|
848 Participants
n=1268 Participants
|
|
Drinking Habits
Unknown
|
266 Participants
n=1268 Participants
|
|
Presence of Stress as a Risk Factor of Gastric or Duodenal Ulcer
Present
|
162 Participants
n=1268 Participants
|
|
Presence of Stress as a Risk Factor of Gastric or Duodenal Ulcer
Absent
|
670 Participants
n=1268 Participants
|
|
Presence of Stress as a Risk Factor of Gastric or Duodenal Ulcer
Unknown
|
436 Participants
n=1268 Participants
|
|
Prior Treatment with Acid Suppressants to Prevent Recurrent Gastric or Duodenal Ulcer
Had Prior Treatment with Acid Suppressants
|
505 Participants
n=1268 Participants
|
|
Prior Treatment with Acid Suppressants to Prevent Recurrent Gastric or Duodenal Ulcer
Had No Prior Treatment with Acid Suppressants
|
661 Participants
n=1268 Participants
|
|
Prior Treatment with Acid Suppressants to Prevent Recurrent Gastric or Duodenal Ulcer
Unknown
|
102 Participants
n=1268 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
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.
Outcome measures
| Measure |
Vonoprazan 10 mg
n=1268 Participants
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.
|
|---|---|
|
Percentage of Participants Who Had One or More Adverse Drug Reactions
|
0.71 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: 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.
The presence or absence of onset of gastric ulcers was reported. Reporting data was total percentage of participants with gastric ulcers.
Outcome measures
| Measure |
Vonoprazan 10 mg
n=1245 Participants
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.
|
|---|---|
|
Percentage of Participants With Gastric Ulcers
|
0.56 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: 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.
The presence or absence of onset of duodenal ulcers was reported. Reporting data was total percentage of participants with duodenal ulcers.
Outcome measures
| Measure |
Vonoprazan 10 mg
n=1245 Participants
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.
|
|---|---|
|
Percentage of Participants With Duodenal Ulcers
|
0.16 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: 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.
The presence or absence of onset of gastric hemorrhagic lesions was reported. Reporting data was total percentage of participants with gastric hemorrhagic lesions.
Outcome measures
| Measure |
Vonoprazan 10 mg
n=1245 Participants
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.
|
|---|---|
|
Percentage of Participants With Gastric Hemorrhagic Lesions
|
0.24 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: 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.
The presence or absence of onset of duodenal hemorrhagic lesions was reported. Reporting data was total percentage of participants with duodenal hemorrhagic lesions.
Outcome measures
| Measure |
Vonoprazan 10 mg
n=1245 Participants
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.
|
|---|---|
|
Percentage of Participants With Duodenal Hemorrhagic Lesions
|
0.08 Percentage of Participants
|
Adverse Events
Vonoprazan 10 mg
Serious events: 17 serious events
Other events: 21 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Vonoprazan 10 mg
n=1268 participants at risk
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.
|
|---|---|
|
Infections and infestations
Pneumonia
|
0.08%
1/1268 • 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.
|
|
Infections and infestations
Sepsis
|
0.08%
1/1268 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.08%
1/1268 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.08%
1/1268 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.08%
1/1268 • 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.
|
|
Nervous system disorders
Cerebral infarction
|
0.08%
1/1268 • 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.
|
|
Nervous system disorders
Parkinson's disease
|
0.08%
1/1268 • 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.
|
|
Eye disorders
Ulcerative keratitis
|
0.08%
1/1268 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.08%
1/1268 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.08%
1/1268 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.08%
1/1268 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.08%
1/1268 • 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.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.08%
1/1268 • 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.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.08%
1/1268 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.08%
1/1268 • 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.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.08%
1/1268 • 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.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.08%
1/1268 • 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.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.16%
2/1268 • 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.
|
|
Injury, poisoning and procedural complications
Injury
|
0.08%
1/1268 • 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.
|
Other adverse events
| Measure |
Vonoprazan 10 mg
n=1268 participants at risk
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.
|
|---|---|
|
Infections and infestations
Bronchitis
|
0.16%
2/1268 • 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.
|
|
Infections and infestations
Cystitis
|
0.16%
2/1268 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
0.16%
2/1268 • 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.
|
|
Infections and infestations
Pharyngitis
|
0.16%
2/1268 • 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.
|
|
Infections and infestations
Helicobacter infection
|
0.16%
2/1268 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.32%
4/1268 • 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.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.16%
2/1268 • 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.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.24%
3/1268 • 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.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.16%
2/1268 • 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.
|
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