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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Francis KL Chan, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01140828
First received: June 9, 2010
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Osteoarthritis
Arthritis, Rheumatoid
Dyspepsia
Drug: Rabeprazole
Drug: Rabeprazole Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • 12-week cumulative incidence of gastric/duodenal ulcer, >10 erosions or severe dyspepsia [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 112
Study Start Date: May 2009
Estimated Study Completion Date: June 2014
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rabeprazole
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01140828

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

No publications provided

Responsible Party: Francis KL Chan, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01140828     History of Changes
Other Study ID Numbers: RAN Study
Study First Received: June 9, 2010
Last Updated: November 27, 2013
Health Authority: Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:
Arthritis
Bone pain
dyspepsia

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

ClinicalTrials.gov processed this record on April 16, 2014