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

AstraZeneca400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

400

Conditions

NSAID Associated Gastric Ulcers

Interventions

EsomeprazoleDRUG

20mg Oral tablet once daily

RanitidineDRUG

150mg oral twice daily

EsomeprazoleDRUG

40mg oral tablet once daily

Eligibility

Min age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

To assess the safety and efficacy of esomeprazole 40 mg qd versus ranitidine 150 mg bid through 8 weeks of treatment for the healing of gastric ulcers in patients receiving daily NSAID therapy. Healing is defined as the absence of gastric ulcers.

Secondary Outcomes

Patient and investigator assessed GI symptoms for up to 8 weeks of treatment.

Time frame: Assessments at week 0, week 4 and week 8

Safety and tolerability of the treatments for 8 weeks of treatment.

Time frame: Assessments at week 0, week 4 and week 8

Data from ClinicalTrials.gov

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