Clinical trial NCT02099708: Long-term Use of Takepron on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs
Official title: Takepron Capsules 15/ Orally Dispersing（OD） Tablets 15 Special Drug Use Surveillance Long-term Use Survey on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric or Duodenal Ulcers
Keywords: Pharmacological therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-03-31
Enrollment: 3502
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Gastric or duodenal ulcers

Brief summary: 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)

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 non-steroidal anti-inflammatory drugs (NSAIDs).

The usual adult dosage is 15 mg of lansoprazole administered orally once daily.

Eligibility 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:

* (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

Primary outcomes:
measure: Frequency of Adverse Drug Reactions
timeFrame: 12 months
Secondary outcomes:
measure: Presence or Absence of Endoscopic Examinations
timeFrame: From baseline to 12 months
measure: Presence of Gastric or Duodenal Ulcer
timeFrame: From baseline to 12 months
measure: Presence of Onset of Gastric or Duodenal Hemorrhagic Lesion
timeFrame: From baseline to 12 months
measure: Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion
timeFrame: From baseline to 12 months
measure: Treatment for Gastric/Duodenal Ulcer or Lesion
timeFrame: From baseline to 12 months
measure: Details of Treatment for Gastric or Duodenal Ulcers or Hemorrhagic Lesions
timeFrame: From baseline to 12 months
measure: Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions
timeFrame: From baseline to 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Postmarketing Group Manager
role: STUDY_CHAIR
References: