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

NCT01140828 | Completed Phase 3

• 1 other identifier: RAN Study
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis; Arthritis, Rheumatoid; Dyspepsia

Keywords

Arthritis; Bone pain; dyspepsia

Outcome Measures

Primary Outcomes (1)

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

  3 months

Study Arms (2)

Rabeprazole

ACTIVE COMPARATOR

Rabeprazole

Drug: Rabeprazole

Rabeprazole Placebo

PLACEBO COMPARATOR

Rabeprazole Placebo

Drug: Rabeprazole Placebo

Interventions

Rabeprazole DRUG

Rabeprazole 20mg once daily

Also known as: Pariet

Rabeprazole

Rabeprazole Placebo DRUG

one tab once daily

Also known as: Pariet Placebo

Rabeprazole Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong, China

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid; Dyspepsia; Arthritis

Interventions

Rabeprazole

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Francis K Chan, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 9, 2010
• First Posted: June 10, 2010
• Study Start: May 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: June 1, 2015
• Last Updated: August 24, 2015

Record last verified: 2015-08

Locations

CN (1)