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Long-term Use of Takepron Capsules on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin

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Takeda

Status

Completed

Conditions

Gastric or Duodenal Ulcers

Treatments

Drug: Lansoprazole

Study type

Observational

Funder types

Industry

Identifiers

NCT02099682
467-712
JapicCTI-R150735 (Registry Identifier)
JapicCTI-142414 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

3,366 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

3,366 participants in 1 patient group

Lansoprazole 15 mg
Description:
Lansoprazole 15 mg orally once daily
Treatment:
Drug: Lansoprazole

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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