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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01140828
• Other study ID #: RAN Study
• Status: Completed
• Phase: Phase 3
• First received: June 9, 2010
• Last updated: August 21, 2015
• Start date: May 2009
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: June 2015
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Dyspepsia
• Osteoarthritis

Intervention

Drug:
• Rabeprazole
Rabeprazole 20mg once daily
• Rabeprazole Placebo
one tab once daily

Locations

Country	Name	City	State
China	Prince of Wales Hospital	Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12-week cumulative incidence of gastric/duodenal ulcer, >10 erosions or severe dyspepsia		3 months	No