Gastric or duodenal ulcers
Conditions
Interventions
investigational material(s)
Generic name etc : Takepron Capsules 15, Takepron OD Tablets 15 (lansoprazole)
INN of investigational material :
Therapeutic category code : 232 Agents for peptic ulcer
D
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patients with a history of gastric or duodenal ulcers (2) Patients requiring long-term use of NSAIDs for reasons such as pain management for rheumatoid arthritis or osteoarthritis (3) Patients taking oral NSAIDs at the start of administration of lansoprazole (including patients who start NSAIDs on the same day as the start of administration of lansoprazole)
Exclusion criteria
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 |
|---|---|
| Frequency of adverse drug reactions Primary timeframe 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 |
|---|---|
| Onset of any gastric or duodenal ulcers or hemorrhagic lesions after the start of administration of lansoprazole therapy Secondary timeframe From baseline to 12 months Summary of data on the presence or absence of endoscopic examinations, onset of gastric or duodenal ulcers, onset of gastric or duodenal hemorrhagic lesions, and details of treatment and outcome of treatment for gastric or duodenal ulcers or hemorrhagic lesions. | — |
Outcome results
None listed