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

August 21, 2015 updated by: Francis KL Chan, Chinese University of Hong Kong

A Double-blind Randomized Placebo Controlled Trial of Rabeprazole for Prevention of NSAID-associated Dyspepsia and Gastroduodenal Injury

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

112

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hong Kong
      • Hong Kong, Hong Kong, China
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Rabeprazole
Drug: Rabeprazole
Rabeprazole 20mg once daily
Other Names:
  • Pariet
Placebo Comparator: Rabeprazole Placebo
Drug: Rabeprazole Placebo
one tab once daily
Other Names:
  • Pariet Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
12-week cumulative incidence of gastric/duodenal ulcer, >10 erosions or severe dyspepsia
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

June 9, 2010

First Submitted That Met QC Criteria

June 9, 2010

First Posted (Estimate)

June 10, 2010

Study Record Updates

Last Update Posted (Estimate)

August 24, 2015

Last Update Submitted That Met QC Criteria

August 21, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAN Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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