NSAID Associated Gastric Ulcers
Conditions
Keywords
NSAID, Nexium, esomeprazole, Gastric Ulcers
Brief summary
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.
Interventions
DRUGEsomeprazole
20mg Oral tablet once daily
DRUGRanitidine
150mg oral twice daily
Sponsors
AstraZeneca
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Patient and investigator assessed GI symptoms for up to 8 weeks of treatment. | Assessments at week 0, week 4 and week 8 |
| Safety and tolerability of the treatments for 8 weeks of treatment. | Assessments at week 0, week 4 and week 8 |
Outcome results
None listed