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

Primary Purpose

Osteoarthritis, Arthritis, Rheumatoid, Dyspepsia

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Rabeprazole

Rabeprazole Placebo

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Arthritis, Bone pain, dyspepsia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Rabeprazole

Rabeprazole Placebo

Arm Description

Rabeprazole

Rabeprazole Placebo

Outcomes

Primary Outcome Measures

12-week cumulative incidence of gastric/duodenal ulcer, >10 erosions or severe dyspepsia

Secondary Outcome Measures

Full Information

NCT ID

NCT01140828

First Posted

June 9, 2010

Last Updated

August 21, 2015

Sponsor

Chinese University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT01140828

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

May 2009 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Arthritis, Rheumatoid, Dyspepsia

Keywords

Arthritis, Bone pain, dyspepsia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Rabeprazole

Arm Type

Active Comparator

Arm Description

Rabeprazole

Arm Title

Rabeprazole Placebo

Arm Type

Placebo Comparator

Arm Description

Rabeprazole Placebo

Intervention Type

Drug

Intervention Name(s)

Rabeprazole

Other Intervention Name(s)

Pariet

Intervention Description

Rabeprazole 20mg once daily

Intervention Type

Drug

Intervention Name(s)

Rabeprazole Placebo

Other Intervention Name(s)

Pariet Placebo

Intervention Description

one tab once daily

Primary Outcome Measure Information:

Title

12-week cumulative incidence of gastric/duodenal ulcer, >10 erosions or severe dyspepsia

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francis K Chan, MD

Organizational Affiliation

Chinese University of Hong Kong

Official's Role

Principal Investigator

Facility Information:

Facility Name

Prince of Wales Hospital

City

Hong Kong

State/Province

Hong Kong

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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