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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: March 4, 2013
Last verified: March 2013
History of Changes
  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:

U.S. FDA Resources

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: 160
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: March 4, 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
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 May 16, 2013