Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis; Gastric Ulcer; Lumbago; Rheumatoid Arthritis; Duodenal Ulcer

Treatments: Drug: Esomeprazole 20 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00595517

D961HC00005

Details and patient eligibility

About

The purpose of this study is to assess the Safety and tolerability of D961H (Esomeprazole) 20 mg once daily for up to 52 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating AE, clinical laboratory value and vital signs.

Enrollment: 395 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Medical history of gastric and/or duodenal ulcer
• A diagnosis of a chronic condition (rheumatoid arthritis, osteoarthritis, lumbago,etc) that requires daily NSAID use,at least 20 years of age

Exclusion criteria

• Having gastric or duodenal ulcer in active or healing stage according to the Sakita/Miwa classification
• History of esophageal, gastric or duodenal surgery
• Having severe liver disease or chronic renal disease

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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395 participants in 1 patient group

Esomeprazole 20 mg

Experimental group

Description:

Esomeprazole 20 mg once daily

Treatment:

Drug: Esomeprazole 20 mg