A Study of Rabeprazole for Prevention of Non Steroidal Anti-inflammatory Drug -Associated Gastrod… (NCT01140828) | Clinical Trial Compass
CompletedPhase 3
A Study of Rabeprazole for Prevention of Non Steroidal Anti-inflammatory Drug -Associated Gastroduodenal Injury
China112 participantsStarted 2009-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 repl…
What they're measuring
1
12-week cumulative incidence of gastric/duodenal ulcer, >10 erosions or severe dyspepsia