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

NCT ID: NCT01140828

Last Updated: 2015-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2015-06-30

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) and/or bone pain.

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 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.

Conditions

Osteoarthritis; Arthritis, Rheumatoid; Dyspepsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Rabeprazole

Rabeprazole

Group Type: ACTIVE_COMPARATOR

Rabeprazole

Intervention Type: DRUG

Rabeprazole 20mg once daily

Rabeprazole Placebo

Rabeprazole Placebo

Group Type: PLACEBO_COMPARATOR

Rabeprazole Placebo

Intervention Type: DRUG

one tab once daily

Interventions

Rabeprazole

Rabeprazole 20mg once daily

Intervention Type: DRUG

Rabeprazole Placebo

one tab once daily

Intervention Type: DRUG

Other Intervention Names

Pariet; Pariet Placebo

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Francis KL Chan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francis K Chan, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Prince of Wales Hospital

Hong Kong, Hong Kong, China

Countries

China

Other Identifiers

RAN Study

Identifier Type: -

Identifier Source: org_study_id