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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-153003 | Registry Identifier | JapicCTI |
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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.
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
If H. pylori eradication with a three-drug regimen comprising vonoprazan or proton pump inhibitor + amoxicillin hydrate + clarithromycin has been unsuccessful.
Second-line eradication
This multi-center trial will be conducted in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vonoprazan 20 mg | For adults, the following three-drug regimen will be 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 may be increased as clinically warranted. However, dosage should not 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 has been unsuccessful, as an alternative treatment, the following three drugs will be 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 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 | 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). | Up to 7 days and 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of participants receiving first-line eradication and second-line eradication including Takecab tablets (triple therapy) 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 |
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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 took part in the study at 58 investigative sites in Japan, from 01 September 2015 to 30 April 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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). | Safety Analysis Set; The safety analysis set was defined as all participants who completed the study. | Posted | Number | Percentage of Participants | Up to 7 days and 2 months |
|
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.
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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 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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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 | Feb 23, 2018 | Dec 25, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 8, 2017 | Dec 25, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D004381 | Duodenal Ulcer |
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C552956 | 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine |
| D017291 | Clarithromycin |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Amoxicillin hydrate | Drug | Amoxicillin hydrate (potency) |
|
| Clarithromycin | Drug | Clarithromycin (potency) |
|
| Metronidazole | Drug | Metronidazole |
|
| 7 days + 2 months |
| 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 | Number | Participants |
|
| Trial Indications | EGC=Early Gastric Cancer. Participants could be counted in more than 1 category (including duplicates). | Count of Participants | Participants |
|
| Healthcare Category | Participants were categorized as outpatient, inpatient. | Count of Participants | Participants |
|
| Predisposition to Hypersensitivity | The baseline characteristic was analyzed in participants who had a liability or tendency to suffer from hypersensitivity. | 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 |
|
| Pre-Therapy of H. Pylori Eradication before Study | 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). | 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 | kg/m^2 |
|
| Smoking Classification | Count of Participants | Participants |
|
| Drinking Habits | Participants who answered Yes or No for a question "Drink Alcohol Almost Every Day?" were reported. | Count of Participants | Participants |
|
| Diagnostic Test for H. Pylori Infection | Participants could be counted in more than 1 category (including duplicates). | Count of Participants | Participants |
|
| Treatment | Count of Participants | 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). | 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. | Posted | Number | 95% Confidence Interval | Percent | 7 days + 2 months |
|
|
|
| 0 |
| 550 |
| 0 |
| 550 |
| 22 |
| 550 |
| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hypogeusia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Faeces hard | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Faeces soft | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 20.0 | Systematic Assessment |
|
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.
| D004066 |
| Digestive System Diseases |
| D013272 | Stomach Diseases |
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| Organic Chemicals |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
|