OsteoarthritisPhase 3NCT01140828
A Study of Rabeprazole for Prevention of Non Steroidal Anti-inflammatory Drug -Associated Gastroduodenal Injury
A Phase 3 study testing Rabeprazole in people with Osteoarthritis and Arthritis, Rheumatoid, run by Chinese University of Hong Kong at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Arthritis, Rheumatoid, Dyspepsia
- What is being tested?
- Rabeprazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- May 2009to Jun 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis, Arthritis, Rheumatoid, Dyspepsia
- Being tested
- Rabeprazole, Rabeprazole Placebo
- Keywords
- Arthritis, Bone pain, dyspepsia
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Dyspepsia, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RabeprazoleDrug
Also called Pariet
Rabeprazole 20mg once daily
Rabeprazole PlaceboDrug
Also called Pariet Placebo
one tab once daily
| Study group | Role | What they receive |
|---|---|---|
| Rabeprazole | Active comparator | Rabeprazole Receives: Drug: Rabeprazole |
| Rabeprazole Placebo | Placebo comparator | Rabeprazole Placebo Receives: Drug: Rabeprazole Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-week cumulative incidence of gastric/duodenal ulcer, >10 erosions or severe dyspepsia
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startMay 2009
- Primary completionOct 2012
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francis KL Chan, Chinese University of Hong Kong
- Investigators
- Francis K Chan, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140828
- Sponsor's protocol ID
- RAN Study
- Status last verified
- Aug 2015
- First submitted
- 9 Jun 2010
- Last updated
- 24 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomized Placebo Controlled Trial of Rabeprazole for Prevention of NSAID-associated Dyspepsia and Gastroduodenal Injury
- ClinicalTrials.gov ID
- NCT01140828
- Acronym / sponsor ID
- RAN Study
- Conditions
- Osteoarthritis, Arthritis, Rheumatoid, Dyspepsia
- Keywords
- Arthritis, Bone pain, dyspepsia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 10 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rabeprazole | Active comparator | Drug: RabeprazoleRabeprazole |
| Rabeprazole Placebo | Placebo comparator | Drug: Rabeprazole PlaceboRabeprazole Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RabeprazoleAlso: ParietRabeprazole 20mg once daily | Drug | Rabeprazole |
| Rabeprazole PlaceboAlso: Pariet Placeboone tab once daily | Drug | Rabeprazole Placebo |
Primary outcome
12-week cumulative incidence of gastric/duodenal ulcer, >10 erosions or severe dyspepsia
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2015.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis K Chan, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rabeprazole in people with Osteoarthritis and Arthritis, Rheumatoid, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-week cumulative incidence of gastric/duodenal ulcer, >10 erosions or severe dyspepsia (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2015.