Gastric or Duodenal Ulcers
Conditions
Keywords
Pharmacological therapy
Brief summary
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
Detailed description
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.
Interventions
DRUGLansoprazole
Lansoprazole Capsules 15/ OD Tablets
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* (1) Patients with a history of gastric or duodenal ulcers (2) Patients requiring long-term use of low-dose aspirin (81-324 mg once daily) as prophylaxis for thromboembolism (3) Patients taking low-dose oral aspirin (81-324 mg once daily) at the start of administration of lansoprazole (including patients who start low-dose aspirin on the same day as the start of administration of lansoprazole)
Exclusion criteria
* (1) Patients with gastric or duodenal ulcer (in the active \[A1, A2\] or healing \[H1, H2\] stage if assessed endoscopically) at the start of administration of lansoprazole (2) Patients with active upper gastrointestinal hemorrhage at the start of administration of lansoprazole (3) Patients with contraindications for lansoprazole
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Adverse Drug Reactions | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Gastric or Duodenal Ulcer | From baseline to 12 months | Summary of data on the presence or absence of gastric or duodenal ulcers. |
| Presence of Gastric or Duodenal Hemorrhagic Lesion | From baseline to 12 months | Summary of data on the presence or absence of gastric or duodenal hemorrhagic lesions. |
| Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion | From baseline to 12 months | Summary of data on the presence or absence of gastric/duodenal ulcer gastric/duodenal hemorrhagic lesion. |
| Presence or Absence of Endoscopic Examinations | From baseline to 12 months | Summary of data on the presence or absence of endoscopic examinations. |
| Details of Treatment (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | From baseline to 12 months | Summary of data on the details of treatment for gastric or duodenal ulcers or hemorrhagic lesions. |
| Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | From baseline to 12 months | Summary of data on the outcome of treatment for gastric or duodenal ulcers or hemorrhagic lesions. |
| Treatment for Gastric/Duodenal Ulcer or Lesion | From baseline to 12 months | Summary of data on the presence or absence of treatment for duodenal ulcers or hemorrhagic lesions. |
Participant flow
Recruitment details
Participants took part in the study at 460 investigative sites in Japan from August 2010 to January 2014 (N=3366).
Pre-assignment details
Patients with a history of gastric or duodenal ulcers and requiring long-term use of low-dose aspirin were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Lansoprazole 15 mg Lansoprazole 15 mg orally once daily | 3,255 |
| Total | 3,255 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Data Not Available | 51 |
| Overall Study | Lost to Follow-up | 31 |
| Overall Study | Other | 29 |
Baseline characteristics
| Characteristic | Lansoprazole 15 mg |
|---|---|
| Age, Continuous | 72.4 years STANDARD_DEVIATION 11.02 |
| Gastric or Duodenal Ulcer History Breakdown Duodenal ulcer | 313 participants |
| Gastric or Duodenal Ulcer History Breakdown Gastric ulcer | 2718 participants |
| Gastric or Duodenal Ulcer History Breakdown Unknown | 252 participants |
| Gastric or Duodenal Ulcer History: Time of Onset 1 year or longer before the start of treatment | 977 participants |
| Gastric or Duodenal Ulcer History: Time of Onset ≥ 6 months, < 1 year before start of treatment | 138 participants |
| Gastric or Duodenal Ulcer History: Time of Onset Unknown | 1927 participants |
| Gastric or Duodenal Ulcer History: Time of Onset Within 6 months of study drug administration | 213 participants |
| H. pylori infection Negative | 425 participants |
| H. pylori infection Positive | 171 participants |
| H. pylori infection Unknown | 2659 participants |
| Purpose for Low-Dose Aspirin Use Angina pectoris | 1182 participants |
| Purpose for Low-Dose Aspirin Use Cerebral infarction | 1225 participants |
| Purpose for Low-Dose Aspirin Use Myocardial infarction | 531 participants |
| Purpose for Low-Dose Aspirin Use Other | 316 participants |
| Purpose for Low-Dose Aspirin Use Post-coronary artery bypass (CABG) | 106 participants |
| Purpose for Low-Dose Aspirin Use PTCA | 398 participants |
| Purpose for Low-Dose Aspirin Use Transient ischaemic attack (TIA) | 221 participants |
| Sex: Female, Male Female | 1399 Participants |
| Sex: Female, Male Male | 1856 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 3,255 |
| serious Total, serious adverse events | 126 / 3,225 |
Outcome results
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.
Time frame: 12 months
Population: Safety analysis set - All participants who received at least 1 dose of lansoprazole.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Enteritis infectious | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Lymphoma | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Diabetes mellitus | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Anxiety | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Dizziness | 2 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Dysgeusia | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Headache | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Loss of consciousness | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Sudden hearing loss | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Abdominal discomfort | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Abdominal distension | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Abdominal pain | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Colitis | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Constipation | 2 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Diarrhoea | 23 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Enterocolitis | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Gastrooesophageal reflux disease | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Haematochezia | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Nausea | 4 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Colitis microscopic | 3 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Hypoaesthesia oral | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Faeces soft | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Drug eruption | 3 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Eczema | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Hypersensitivity vasculitis | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Pruritus | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Rash generalised | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Back pain | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Osteoporosis | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Renal failure chronic | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Sudden death | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Thirst | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Hepatic enzyme increased | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Glycosylated haemoglobin increased | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Weight decreased | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Fall | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Spinal fracture | 1 participants |
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.
Time frame: From baseline to 12 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lansoprazole 15 mg | Details of Treatment (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Other | 5 participants |
| Lansoprazole 15 mg | Details of Treatment (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Takepron Capsule or OD Tablet 15 mg | 15 participants |
| Lansoprazole 15 mg | Details of Treatment (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Takepron Capsule or OD Tablet 30 mg | 2 participants |
| Lansoprazole 15 mg | Details of Treatment (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Rabeprazole tablet 10 mg | 2 participants |
| Lansoprazole 15 mg | Details of Treatment (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | H2 receptor antagonist (oral) | 1 participants |
| Lansoprazole 15 mg | Details of Treatment (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Omeprazole (injection) | 2 participants |
| Lansoprazole 15 mg | Details of Treatment (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | H2 receptor antagonist (injection) | 1 participants |
| Lansoprazole 15 mg | Details of Treatment (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Other peptic ulcer drugs | 2 participants |
| Lansoprazole 15 mg | Details of Treatment (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Endoscopic hemostasis | 1 participants |
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.
Time frame: From baseline to 12 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lansoprazole 15 mg | Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion | Present | 3186 participants |
| Lansoprazole 15 mg | Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion | Absent | 24 participants |
Secondary
Presence of Gastric or Duodenal Hemorrhagic Lesion
Summary of data on the presence or absence of gastric or duodenal hemorrhagic lesions.
Time frame: From baseline to 12 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lansoprazole 15 mg | Presence of Gastric or Duodenal Hemorrhagic Lesion | Present | 3201 participants |
| Lansoprazole 15 mg | Presence of Gastric or Duodenal Hemorrhagic Lesion | Absent | 9 participants |
Secondary
Presence of Gastric or Duodenal Ulcer
Summary of data on the presence or absence of gastric or duodenal ulcers.
Time frame: From baseline to 12 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lansoprazole 15 mg | Presence of Gastric or Duodenal Ulcer | Present | 3190 participants |
| Lansoprazole 15 mg | Presence of Gastric or Duodenal Ulcer | Absent | 20 participants |
Secondary
Presence or Absence of Endoscopic Examinations
Summary of data on the presence or absence of endoscopic examinations.
Time frame: From baseline to 12 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lansoprazole 15 mg | Presence or Absence of Endoscopic Examinations | With endoscopy | 2773 participants |
| Lansoprazole 15 mg | Presence or Absence of Endoscopic Examinations | Without endoscopy | 437 participants |
Secondary
Treatment for Gastric/Duodenal Ulcer or Lesion
Summary of data on the presence or absence of treatment for duodenal ulcers or hemorrhagic lesions.
Time frame: From baseline to 12 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lansoprazole 15 mg | Treatment for Gastric/Duodenal Ulcer or Lesion | Absent | 24 participants |
| Lansoprazole 15 mg | Treatment for Gastric/Duodenal Ulcer or Lesion | Present | 0 participants |
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.
Time frame: From baseline to 12 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lansoprazole 15 mg | Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Takepron 15 mg: Recovery | 9 participants |
| Lansoprazole 15 mg | Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Takepron 15 mg: Relief | 6 participants |
| Lansoprazole 15 mg | Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Takepron 30 mg: Recovery | 1 participants |
| Lansoprazole 15 mg | Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Takepron 30 mg: Relief | 1 participants |
| Lansoprazole 15 mg | Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Rabeprazole 10 mg: Recovery | 1 participants |
| Lansoprazole 15 mg | Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Rabeprazole 10 mg: Relief | 1 participants |
| Lansoprazole 15 mg | Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | H2 receptor antagonist (orally): Recovery | 1 participants |
| Lansoprazole 15 mg | Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | H2 receptor antagonist (orally): Relief | 1 participants |
| Lansoprazole 15 mg | Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Omeprazole (injection): Recovery | 1 participants |
| Lansoprazole 15 mg | Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Omeprazole (injection): Relief | 1 participants |
| Lansoprazole 15 mg | Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | H2 receptor antagonist (injection): Recovery | 2 participants |
| Lansoprazole 15 mg | Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | H2 receptor antagonist (injection): Relief | 1 participants |
| Lansoprazole 15 mg | Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Other peptic ulcer drugs: Recovery | 3 participants |
| Lansoprazole 15 mg | Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Other peptic ulcer drugs: Relief | 2 participants |
| Lansoprazole 15 mg | Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Endoscopic hemostasis: Recovery | 9 participants |
| Lansoprazole 15 mg | Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Endoscopic hemostasis: Relief | 6 participants |
| Lansoprazole 15 mg | Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Other: Recovery | 1 participants |
| Lansoprazole 15 mg | Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Other: Relief | 1 participants |