A Study of Rabeprazole for Prevention of Non Steroidal Anti-inflammatory Drug -Associated Gastroduodenal Injury

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to determine whether rabeprazole is superior to placebo in preventing dyspepsia and gastroduodenal injury in subjects with osteoarthritis (OA) and/or rheumatoid arthritis (RA) and/or bone pain.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Treatments: Anti-Inflammatory Agents, Non-Steroidal; Rabeprazole

Criteria

Inclusion Criteria:

• Outpatient or inpatient subjects with a clinical diagnosis of OA or RA or any bone pain

• Subjects expected to require regular anti-inflammatory therapy for arthritis symptom management

• Subjects should have no history of peptic ulcer complications

• Screening tests are negative for H pylori

• Subjects who test positive can be re-screened after eradication of H. pylori

Exclusion Criteria:

• History of gastrointestinal (GI) hemorrhage

• History of gastric or duodenal surgery

• Presence of erosive esophagitis, gastric-outlet obstruction

• Likelihood of requiring treatment during the study with drugs not permitted by the protocol

• Impaired hepatic function (SGPT (ALT) or serum glutamate oxaloacetate transaminase (SGOT) (AST) > 2 x upper limit of normal) or renal function (serum creatinine > 200 umol/l)

• Any other condition or baseline finding which, in the investigator's judgment, might increase risk to the subject or decrease the chance of obtaining satisfactory data to achieve study objectives

• Anemia with Hb < 10 g/dL

• Suspected or clinical diagnosis of inflammatory bowel disease

• Congestive heart failure (NYHA class III- IV)

• Subjects considered to have a requirement for continued use of:

• Corticosteroids (dose equivalent of prednisolone/ prednisone >10mg daily stable dose)

• disease-modifying antirheumatic drug (DMARDs) (unless stable dose for ≥ 12 weeks)

• Iron replacement therapy (a dose > 15mg elemental iron/day)

• Iron replacement therapy (a dose > 15mg elemental iron/day) or supplements for deficiency prevention (a dose ≤ 15mg elemental iron/day) due to anemia or any other reason

• Double anti-platelet therapy (e.g. aspirin + Plavix)

• Anti-coagulants

• Anti-ulcer medications, e.g. sucralfate, H2 receptor antagonists (H2RAs), misoprostol, PPIs other than study medications

• Sucralfate, misoprostol or regular H2 receptor antagonists (H2RAs) (> 3 days/week)

• COX-2 inhibitors

• anti-ulcer medications or COX-2 selective inhibitor at screening allowed if treatments discontinued at this time