Osteoarthritis Clinical Trial
Official title:
A Double-blind Randomized Placebo Controlled Trial of Rabeprazole for Prevention of NSAID-associated Dyspepsia and Gastroduodenal Injury
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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