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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: November 18, 2014
Last verified: November 2014

June 9, 2010
November 18, 2014
May 2009
October 2012   (final data collection date for primary outcome measure)
12-week cumulative incidence of gastric/duodenal ulcer, >10 erosions or severe dyspepsia [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01140828 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study of Rabeprazole for Prevention of Non Steroidal Anti-inflammatory Drug -Associated Gastroduodenal Injury
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Osteoarthritis
  • Arthritis, Rheumatoid
  • Dyspepsia
  • Drug: Rabeprazole
    Rabeprazole 20mg once daily
    Other Name: Pariet
  • Drug: Rabeprazole Placebo
    one tab once daily
    Other Name: Pariet Placebo
  • Active Comparator: Rabeprazole
    Rabeprazole
    Intervention: Drug: Rabeprazole
  • Placebo Comparator: Rabeprazole Placebo
    Rabeprazole Placebo
    Intervention: Drug: Rabeprazole Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
112
June 2015
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01140828
RAN Study
No
Francis KL Chan, Chinese University of Hong Kong
Chinese University of Hong Kong
Not Provided
Principal Investigator: Francis K Chan, MD Chinese University of Hong Kong
Chinese University of Hong Kong
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP