A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: NSAID Associated Gastric Ulcers

Treatments: Drug: Esomeprazole; Drug: Ranitidine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00633672

SH-NEN-0006

Details and patient eligibility

About

Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the treatment of these gastric ulcers with one of the three following treatment groups: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine 150 mg twice daily.

Enrollment: 400 estimated patients

Sex

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. A clinical diagnosis of a chronic condition (eg osteoarthritis or rheumatoid arthritis) that requires daily NSAID treatment for at least 2 months.
2. Other key inclusion criteria, as specified in the protocol.

Exclusion criteria

1. History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer.
2. History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
3. Other conditions and criteria, as specified in the protocol.

Trial design

400 participants in 3 patient groups

1

Experimental group

Description:

20mg Oral tablet daily

Treatment:

Drug: Esomeprazole

Drug: Esomeprazole

2

Experimental group

Description:

40mg oral tablet daily

Treatment:

Drug: Esomeprazole

Drug: Esomeprazole

3

Active Comparator group

Description:

150mg oral twice daily

Treatment:

Drug: Ranitidine