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A Study of Rabeprazole for Prevention of Non Steroidal Anti-inflammatory Drug (NSAID)-Associated Dyspepsia and Gastroduodenal Injury

2014-08-27 03:13:02 | BioPortfolio

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.

Description

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Osteoarthritis

Intervention

Rabeprazole, Rabeprazole Placebo

Location

Prince of Wales Hospital
Hong Kong
China

Status

Recruiting

Source

Chinese University of Hong Kong

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:02-0400

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