Efficacy and Safety of Lansoprazole on Gastric and Duodenal Ulcers in Patients Taking Nonsteroidal Anti-Inflammatory Drugs

Takeda

Status and phase

Completed

Phase 3

Conditions

Duodenal Ulcer

Stomach Ulcer

Treatments

Drug: Lansoprazole

Drug: Gefarnate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00787254

U1111-1114-2071 (Registry Identifier)

R100126 (Registry Identifier)

070495 (Registry Identifier)

AG-1749-CCT-352

Details and patient eligibility

About

The purpose of this study is to determine whether AG-1749 (lansoprazole), once daily (QD), is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term treatment with nonsteroid anti-inflammatory drug, compared to gefarnate, twice daily (BID).

Full description

In Japan, nonsteroid anti-inflammatory drug is one of common prescribed drugs for patients as an analgesic antipyretic, treating symptoms of cold, antiphlogistic and management of pain with rheumatoid arthritis, osteoarthrosis, lumbago. On the other hand, this nonsteroid anti-inflammatory drug sometimes causes gastric and duodenal ulcers and this ulcer leads to the gastrointestinal bleeding which may be cause of death.

The purpose of this study is to assess the efficacy of lansoprazole versus gefarnate in patients with a history of gastric or duodenal ulcers receiving daily nonsteroid anti-inflammatory medication.

Enrollment

366 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The patient was on nonsteroid anti-inflammatory drug (NSAID) treatment on the day when consent was obtained, and requires the long-term continuous treatment even after treatment with the investigational drug is started.
The patient was confirmed to have a history of gastric ulcer or duodenal ulcer.

Exclusion criteria

Endoscopically confirmed gastric and/or duodenal ulcers on Day 1.
Endoscopically confirmed active upper gastrointestinal hemorrhage on Day 1.
Current or past history of aspirin-induced asthma or hypersensitivity to NSAIDs.
Past or planned surgery affecting gastric acid secretion.
Clinically significant hepatic or renal disorder.
Serious cardiac dysfunction, hypertension, or hematological disorder.