CompletedPhase 3

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 in Subjects in the US Only

400 participantsStarted 2001-02

Plain-language 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 for up to 8 weeks: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine 150 mg twice daily for subjects in the US only.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * A clinical diagnosis of a chronic condition (eg osteoarthritis or rheumatoid arthritis) that requires daily NSAID treatment for at least 2 months. * A gastric ulcer \>= 5mm in diameter, but no ulcer \>25 mm at its greatest diameter, at the baseline endoscopy. * Other key inclusion criteria, as specified in the protocol. Exclusion Criteria: * History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer. * History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis. * Many other conditions and criteria, as specified in the protocol.

What they're measuring

The proportion of patients with no gastric ulcers after 8 weeks of treatment.

Timeframe: Esophagogastroduodenscopy (EGD) assessments at baseline, week 4, week 8, and efficacy evaluations at each visit including endoscopic evaluation for the presence of ulcers and erosions.

Trial details

NCT IDNCT00633412

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More NSAID Associated Gastric Ulcers trials