a study of rabeprazole for prevention of non steroidal anti-inflammatory drug -associated gastroduodenal injury

Conditions: Osteoarthritis; Arthritis, Rheumatoid; Dyspepsia

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.

non steroidal anti-inflammatory drugs (nsaids) are well known to increase the risk of gastroduodenal (gd) ulcer and its complications. up to 40% of average-risk nsaid users suffer from dyspepsia without endoscopic evidence of gastroduodenal injury. it results a significant loss of productivity and impairment of quality of life (qol). proton pump inhibitors (ppis) have been shown to be effective in preventing and reducing nsaid-induced gd injury. ppis are believed to have a class effect but rabeprazole, the least expensive ppi, is grossly under-utilized in this area . current hospital authority (ha) guidelines, however, only endorse the use of ppi in patients at high risk of ulcer bleeding. since nsaid-induced dyspepsia is not an indication for ppi according to ha guidelines, those patients do not receive ppi for treatment.

Eligibility 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

Keywords: arthritis bone pain dyspepsia