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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01140828
Recruitment Status : Completed
First Posted : June 10, 2010
Last Update Posted : August 24, 2015
Information provided by (Responsible Party):
Francis KL Chan, Chinese University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Arthritis, Rheumatoid Dyspepsia Drug: Rabeprazole Drug: Rabeprazole Placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind Randomized Placebo Controlled Trial of Rabeprazole for Prevention of NSAID-associated Dyspepsia and Gastroduodenal Injury
Study Start Date : May 2009
Actual Primary Completion Date : October 2012
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arm Intervention/treatment
Active Comparator: Rabeprazole
Drug: Rabeprazole
Rabeprazole 20mg once daily
Other Name: Pariet

Placebo Comparator: Rabeprazole Placebo
Rabeprazole Placebo
Drug: Rabeprazole Placebo
one tab once daily
Other Name: Pariet Placebo

Primary Outcome Measures :
  1. 12-week cumulative incidence of gastric/duodenal ulcer, >10 erosions or severe dyspepsia [ Time Frame: 3 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01140828

China, Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Principal Investigator: Francis K Chan, MD Chinese University of Hong Kong

Responsible Party: Francis KL Chan, Professor, Chinese University of Hong Kong Identifier: NCT01140828     History of Changes
Other Study ID Numbers: RAN Study
First Posted: June 10, 2010    Key Record Dates
Last Update Posted: August 24, 2015
Last Verified: August 2015

Keywords provided by Francis KL Chan, Chinese University of Hong Kong:
Bone pain

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents