Long-term Use of Takepron Capsules on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin
- Registration Number
- NCT02099682
- Lead Sponsor
- Takeda
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3366
- (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)
- (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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Lansoprazole 15 mg Lansoprazole Lansoprazole 15 mg orally once daily
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
Presence or Absence of Endoscopic Examinations From baseline to 12 months Summary of data on the presence or absence of endoscopic examinations.
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.
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.
Presence of Gastric or Duodenal Ulcer From baseline to 12 months Summary of data on the presence or absence of gastric or duodenal ulcers.