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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-142418 | Registry Identifier | Japic CTI | |
| JapicCTI-R150705 | 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) therapy for up to 12 months in the routine clinical setting in patients receiving oral non-steroidal anti-inflammatory drugs (NSAIDs)
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 non-steroidal anti-inflammatory drugs (NSAIDs).
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, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lansoprazole | Drug | Lansoprazole Capsules 15 mg/ Orally Disintegrating (OD) Tablets 15 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Adverse Drug Reactions | Frequency was defined as the number of participants for each adverse event 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 gastric or duodenal ulcers by using endoscopic examinations. | From baseline to 12 months |
| Presence of Gastric or Duodenal Ulcer |
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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 |
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Patients with a history of gastric or duodenal ulcers and requiring long-term use of nonsteroidal anti-inflammatory drugs were enrolled in the study.
Participants took part in the study at 501 investigative sites in Japan from October 2010 to March 2014 (N=3,502).
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| ID | Title | Description |
|---|---|---|
| FG000 | Lansoprazole 15 mg | Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months. |
| 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, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months. |
| 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 was defined as the number of participants for each adverse event 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 (SAS) - All participants who received at least 1 dose of open-label study drug. | Posted | Number | participants | 12 months |
|
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, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA version 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 |
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| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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Summary of data on the presence or absence of gastric or duodenal ulcer.
| From baseline to 12 months |
| Presence of Onset of Gastric or Duodenal Hemorrhagic Lesion | Summary of data on the presence or absence of gastric or duodenal hemorrhagic lesion. | 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 for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Summary of data on the details of treatment for gastric or duodenal ulcers or hemorrhagic lesions. Participants could be counted in more than 1 treatment category. | 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 of Non-steroidal Anti-Inflammatory Drug (NSAID) Treatment | Participants could be counted in more than 1 category (including duplicates). | Number | participants |
|
| Details of the History of Gastric or Duodenal Ulcers: Site of Disease | Participants could be counted in more than 1 category (including duplicates). | Number | participants |
|
| Details of the History of Gastric or Duodenal Ulcers: Time of Emergence | Number | participants |
|
| Presence or Absence of H. Pylori Infection | Number | participants |
|
|
|
| Secondary | Presence or Absence of Endoscopic Examinations | Summary of data on the presence or absence of gastric or duodenal ulcers by using endoscopic examinations. | Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole. | 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 ulcer. | Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole. | Posted | Number | Participants | From baseline to 12 months |
|
|
|
| Secondary | Presence of Onset of Gastric or Duodenal Hemorrhagic Lesion | Summary of data on the presence or absence of gastric or duodenal hemorrhagic lesion. | Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole. | 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 from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole. | 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 from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole. | Posted | Number | participants | From baseline to 12 months |
|
|
|
| Secondary | Details of Treatment for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Summary of data on the details of treatment for gastric or duodenal ulcers or hemorrhagic lesions. Participants could be counted in more than 1 treatment category. | Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole. | 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 from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole. | Posted | Number | participants | From baseline to 12 months |
|
|
|
| 50 |
| 3,302 |
| 0 |
| 3,302 |
| Meningitis bacterial | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
|
| Infectious pleural effusion | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.0 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.0 | Systematic Assessment |
|
| Malignant ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.0 | Systematic Assessment |
|
| Mesothelioma malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.0 | Systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.0 | Systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.0 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.0 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.0 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.0 | Systematic Assessment |
|
| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.0 | Systematic Assessment |
|
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.0 | Systematic Assessment |
|
| Mucinous adenocarcinoma of appendix | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.0 | Systematic Assessment |
|
| Ductal adenocarcinoma of pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.0 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Cerebral artery embolism | Nervous system disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Cervical myelopathy | Nervous system disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Coma | Nervous system disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Bladder tamponade | Renal and urinary disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA version 17.0 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA version 17.0 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA version 17.0 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA version 17.0 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA version 17.0 | Systematic Assessment |
|
| Nephrectomy | Surgical and medical procedures | MedDRA version 17.0 | Systematic Assessment |
|
| Incisional drainage | Surgical and medical procedures | MedDRA version 17.0 | Systematic Assessment |
|
| Spinal operation | Surgical and medical procedures | MedDRA version 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 |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| Title | Measurements |
|---|---|
|
| Rabeprazole tablet 20 mg |
|
| H2 receptor antagonist (oral) |
|
| Other peptic ulcer medication |
|
| Endoscopic hemostasis |
|
| Other |
|
| Title | Measurements |
|---|---|
|
| Rabeprazole 10 mg _Resolved |
|
| Rabeprazole 20 mg - Resolved |
|
| H2 receptor antagonist - Resolved |
|
| Other peptic ulcer medication - Resolved |
|
| Other peptic ulcer medication - Resolving |
|
| Endoscopic hemostasis - Resolving |
|
| Other - Resolved |
|
| Other - Resolving |
|