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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-163436 | Registry Identifier | JapicCTI |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vonoprazan | Drug | Vonoprazan tablets |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 12 months |
| Percentage of Participants With Duodenal Ulcers |
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Inclusion Criteria:
- Participants with a history of gastric or duodenal ulcer
Exclusion Criteria:
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The study population will consist of participants with a historical diagnosis of gastric or duodenal ulcers and during NSAIDs administration in the routine medical care.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Takeda Selected Site | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36264125 | Derived | Kawai T, Suzuki C, Honda Y, Fernandez JL. Long-term safety and effectiveness of vonoprazan for prevention of gastric and duodenal ulcer recurrence in patients on nonsteroidal anti-inflammatory drugs in Japan: a 12-month post-marketing surveillance study. Expert Opin Drug Saf. 2023 Jan-Jun;22(5):425-431. doi: 10.1080/14740338.2023.2136163. Epub 2022 Oct 20. |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants with a historical diagnosis of gastric or duodenal ulcers were enrolled. Participants received vonoprazan as part of a routine medical care.
Participants took part in the survey at 145 investigative sites in Japan, from 01 September 2016 to 30 April 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 12, 2020 | Jun 2, 2023 |
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The presence or absence of onset of duodenal ulcers was reported. Reporting data was total percentage of participants with duodenal ulcers. |
| Up to 12 months |
| 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. | Up to 12 months |
| 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. | Up to 12 months |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| Medical History (Gastric Ulcer) | Number of participants with or without medical history of Gastric Ulcer was reported. | Count of Participants | Participants |
| |||||||||||||||||
| Medical History (Duodenal Ulcer) | Number of participants with or without medical history of Duodenal Ulcer was reported. | Count of Participants | Participants |
| |||||||||||||||||
| Reason for Use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), Rheumatoid Arthritis | Count of Participants | Participants |
| ||||||||||||||||||
| Reason for Use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) , Osteoarthritis | Count of Participants | Participants |
| ||||||||||||||||||
| Reason for Use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) , Others | Count of Participants | Participants |
| ||||||||||||||||||
| Healthcare Category | Participants were categorized as outpatient and inpatient. | Count of Participants | Participants |
| |||||||||||||||||
| Predisposition to Hypersensitivity | Number of participants who had or did not have a liability or tendency to suffer from hypersensitivity was reported. | Count of Participants | Participants |
| |||||||||||||||||
| Medical Complications | Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above. | Count of Participants | Participants |
| |||||||||||||||||
| Height | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Centimeters (cm) |
| ||||||||||||||||
| Weight | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Kilograms (kg) |
| ||||||||||||||||
| BMI | Body Mass Index = weight (kg)/[height (m)^2] | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Kilogram (kg)/meter (m)^2 |
| |||||||||||||||
| Helicobacter Pylori Infection | Number of participants with or without medical history of H. pylori was reported. "Negative" indicates the absence of H. pylori infection, "Positive" indicates presence of the infection. | Count of Participants | Participants |
| |||||||||||||||||
| Smoking Classification | Count of Participants | Participants |
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| Drinking Habits | Count of Participants | Participants |
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| Presence of Stress as a Risk Factor of Gastric or Duodenal Ulcer | Count of Participants | Participants |
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| Prior Treatment with Acid Suppressants to Prevent Recurrent Gastric or Duodenal Ulcer | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Number | Percentage of Participants | Up to 12 months |
|
|
| ||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | Percentage of Participants | Up to 12 months |
|
| |||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | Percentage of Participants | Up to 12 months |
|
| |||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | Percentage of Participants | Up to 12 months |
|
| |||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | Percentage of Participants | Up to 12 months |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 7 | 1,268 | 17 | 1,268 | 21 | 1,268 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA/J Ver. 23.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA/J Ver. 23.0 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J Ver. 23.0 | Systematic Assessment |
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| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J Ver. 23.0 | Systematic Assessment |
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| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J Ver. 23.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA/J Ver. 23.0 | Systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA/J Ver. 23.0 | Systematic Assessment |
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| Ulcerative keratitis | Eye disorders | MedDRA/J Ver. 23.0 | Systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA/J Ver. 23.0 | Systematic Assessment |
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| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA/J Ver. 23.0 | Systematic Assessment |
| |
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA/J Ver. 23.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA/J Ver. 23.0 | Systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA/J Ver. 23.0 | Systematic Assessment |
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| Jaundice cholestatic | Hepatobiliary disorders | MedDRA/J Ver. 23.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA/J Ver. 23.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA/J Ver. 23.0 | Systematic Assessment |
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| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA/J Ver. 23.0 | Systematic Assessment |
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| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA/J Ver. 23.0 | Systematic Assessment |
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| Injury | Injury, poisoning and procedural complications | MedDRA/J Ver. 23.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA/J Ver. 23.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA/J Ver. 23.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA/J Ver. 23.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA/J Ver. 23.0 | Systematic Assessment |
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| Helicobacter infection | Infections and infestations | MedDRA/J Ver. 23.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA/J Ver. 23.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA/J Ver. 23.0 | Systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA/J Ver. 23.0 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA/J Ver. 23.0 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 9, 2020 | Apr 27, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D004381 | Duodenal Ulcer |
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| C552956 | 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine |
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| Inpatient |
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| Had No Predisposition to Hypersensitivity |
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| Unknown |
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| Had No Medical Complications |
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| Negative |
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| Unknown |
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| Ex-Smoker |
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| Unknown |
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| Unknown |
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| Unknown |
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| Had No Prior Treatment with Acid Suppressants |
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| Unknown |
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