Long-term Use of Takepron on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs

N/ACompletedNCT02099708

Takeda3,502 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

3,502

Conditions

Gastric or Duodenal Ulcers

Interventions

LansoprazoleDRUG

Lansoprazole Capsules 15 mg/ Orally Disintegrating (OD) Tablets 15 mg

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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: * (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

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Secondary Outcomes

Presence or Absence of Endoscopic Examinations

Summary of data on the presence or absence of gastric or duodenal ulcers by using endoscopic examinations.