A Study of Rabeprazole for Prevention of Non Steroidal Anti-inflammatory Drug -Associated Gastroduodenal Injury

The Chinese University of Hong Kong

Status and phase

Completed

Phase 3

Conditions

Osteoarthritis

Dyspepsia

Arthritis, Rheumatoid

Treatments

Drug: Rabeprazole Placebo

Drug: Rabeprazole

Study type

Interventional

Funder types

Other

Identifiers

NCT01140828

RAN Study

Details and patient eligibility

About

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.

Full 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.

Enrollment

112 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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