Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID

AstraZeneca

Status and phase: Completed; Phase 3

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

Treatments: Drug: Placebo; Drug: Esomeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00542789

D961HC00001

Details and patient eligibility

About

The purpose of this study is to assess the efficacy of esomeprazole (D961H) 20 mg versus placebo once daily for up to 24 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating presence or absence of gastric and/or duodenal ulcers throughout the treatment period (24 weeks) in terms of efficacy on prevention of gastric and/or duodenal ulcers

Enrollment: 343 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: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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343 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

2

Experimental group

Description:

Esomeprazole 20 mg

Treatment:

Drug: Esomeprazole