Status:
COMPLETED
A Study of Rabeprazole for Prevention of Non Steroidal Anti-inflammatory Drug -Associated Gastroduodenal Injury
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Osteoarthritis
Arthritis, Rheumatoid
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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)...
Detailed 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 witho...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2015
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT01140828
Start Date
May 1 2009
End Date
June 1 2015
Last Update
August 24 2015
Active Locations (1)
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1
Prince of Wales Hospital
Hong Kong, Hong Kong, China