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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-142414 | Registry Identifier | JapicCTI | |
| JapicCTI-R150735 | Registry Identifier | JapicCTI |
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The purpose of this study is to investigate the safety and efficacy of long-term administration of lansoprazole (Takepron) for up to 12 months in the routine clinical setting in patients receiving low-dose aspirin
This is a special survey on long-term use (for up to 12 months) of lansoprazole (Takepron) to determine the incidence of adverse drug reactions in the routine clinical setting in patients receiving low-dose aspirin.
The usual adult dosage is 15 mg of lansoprazole administered orally once daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lansoprazole 15 mg | Lansoprazole 15 mg orally once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lansoprazole | Drug | Lansoprazole Capsules 15/ OD Tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Adverse Drug Reactions | Frequency, severity, and time to onset of adverse drug reactions tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Presence or Absence of Endoscopic Examinations | Summary of data on the presence or absence of endoscopic examinations. | From baseline to 12 months |
| Presence of Gastric or Duodenal Ulcer | Summary of data on the presence or absence of gastric or duodenal ulcers. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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Gastric or duodenal ulcers
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| Name | Affiliation | Role |
|---|---|---|
| Postmarketing Group Manager | Takeda | Study Chair |
Not provided
Patients with a history of gastric or duodenal ulcers and requiring long-term use of low-dose aspirin were enrolled in the study.
Participants took part in the study at 460 investigative sites in Japan from August 2010 to January 2014 (N=3366).
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| ID | Title | Description |
|---|---|---|
| FG000 | Lansoprazole 15 mg | Lansoprazole 15 mg orally once daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis set: all participants who took the study drug at least once.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lansoprazole 15 mg | Lansoprazole 15 mg orally once daily |
| 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 | Frequency of Adverse Drug Reactions | Frequency, severity, and time to onset of adverse drug reactions tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions. | Safety analysis set - All participants who received at least 1 dose of lansoprazole. | Posted | Number | participants | 12 months |
|
From the first dose of open-label study drug until 14 days (or 30 days for a serious adverse event) after the last dose of open-label study drug (up to 12 months).
Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
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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 | Lansoprazole 15 mg | Lansoprazole 15 mg orally once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Clinical Science | Takeda | 800-778-2860 | clinicaltrialregistry@tpna.com |
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| ID | Term |
|---|---|
| D004381 | Duodenal Ulcer |
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| From baseline to 12 months |
| Presence of Gastric or Duodenal Hemorrhagic Lesion | Summary of data on the presence or absence of gastric or duodenal hemorrhagic lesions. | From baseline to 12 months |
| Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion | Summary of data on the presence or absence of gastric/duodenal ulcer gastric/duodenal hemorrhagic lesion. | From baseline to 12 months |
| Treatment for Gastric/Duodenal Ulcer or Lesion | Summary of data on the presence or absence of treatment for duodenal ulcers or hemorrhagic lesions. | From baseline to 12 months |
| Details of Treatment (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Summary of data on the details of treatment for gastric or duodenal ulcers or hemorrhagic lesions. | From baseline to 12 months |
| Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Summary of data on the outcome of treatment for gastric or duodenal ulcers or hemorrhagic lesions. | From baseline to 12 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Purpose for Low-Dose Aspirin Use | Participants could be counted in more than 1 category. | Number | participants |
|
| Gastric or Duodenal Ulcer History Breakdown | Participants could be counted in more than 1 category. | Number | participants |
|
| Gastric or Duodenal Ulcer History: Time of Onset | Number | participants |
|
| H. pylori infection | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Presence or Absence of Endoscopic Examinations | Summary of data on the presence or absence of endoscopic examinations. | Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed. | Posted | Number | participants | From baseline to 12 months |
|
|
|
| Secondary | Presence of Gastric or Duodenal Ulcer | Summary of data on the presence or absence of gastric or duodenal ulcers. | Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed. | Posted | Number | participants | From baseline to 12 months |
|
|
|
| Secondary | Presence of Gastric or Duodenal Hemorrhagic Lesion | Summary of data on the presence or absence of gastric or duodenal hemorrhagic lesions. | Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed. | Posted | Number | participants | From baseline to 12 months |
|
|
|
| Secondary | Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion | Summary of data on the presence or absence of gastric/duodenal ulcer gastric/duodenal hemorrhagic lesion. | Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed. | Posted | Number | participants | From baseline to 12 months |
|
|
|
| Secondary | Treatment for Gastric/Duodenal Ulcer or Lesion | Summary of data on the presence or absence of treatment for duodenal ulcers or hemorrhagic lesions. | Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed. | Posted | Number | participants | From baseline to 12 months |
|
|
|
| Secondary | Details of Treatment (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Summary of data on the details of treatment for gastric or duodenal ulcers or hemorrhagic lesions. | Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed. | Posted | Number | participants | From baseline to 12 months |
|
|
|
| Secondary | Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Summary of data on the outcome of treatment for gastric or duodenal ulcers or hemorrhagic lesions. | Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed. | Posted | Number | participants | From baseline to 12 months |
|
|
|
| 126 |
| 3,225 |
| 0 |
| 3,255 |
| Gastroenteritis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Psychosomatic disease | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cerebellar infarction | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dyslalia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Intracranial aneurysm | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Thrombotic cerebral infarction | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 17.0 | Systematic Assessment |
|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 17.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Aortic valve stenosis | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Ventricular arrhythmia | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Aortic aneurysm rupture | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Aortic dissection | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Aortic rupture | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Gastric polyps | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Ileal ulcer | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Rectal ulcer | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Alcoholic pancreatitis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Haemorrhagic erosive gastritis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hypersensitivity vasculitis | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Muscle haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Breast mass | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Sudden cardiac death | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Accidental device ingestion | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Failure to anastomose | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Traumatic ulcer | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Traumatic fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Coronary angioplasty | Surgical and medical procedures | MedDRA 17.0 | Systematic Assessment |
|
| Enterostomy | Surgical and medical procedures | MedDRA 17.0 | Systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA 17.0 | 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 |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Title | Measurements |
|---|---|
|
| H2 receptor antagonist (oral) |
|
| Omeprazole (injection) |
|
| H2 receptor antagonist (injection) |
|
| Other peptic ulcer drugs |
|
| Endoscopic hemostasis |
|
| Other |
|
| Title | Measurements |
|---|---|
|
| Takepron 30 mg: Relief |
|
| Rabeprazole 10 mg: Recovery |
|
| Rabeprazole 10 mg: Relief |
|
| H2 receptor antagonist (orally): Recovery |
|
| H2 receptor antagonist (orally): Relief |
|
| Omeprazole (injection): Recovery |
|
| Omeprazole (injection): Relief |
|
| H2 receptor antagonist (injection): Recovery |
|
| H2 receptor antagonist (injection): Relief |
|
| Other peptic ulcer drugs: Recovery |
|
| Other peptic ulcer drugs: Relief |
|
| Endoscopic hemostasis: Recovery |
|
| Endoscopic hemostasis: Relief |
|
| Other: Recovery |
|
| Other: Relief |
|