Rheumatoid ArthritisPhase 3PRESENTNCT00576706
PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal Toxicity
A Phase 3 study testing Rebamipide and Misoprostol in people with Rheumatoid Arthritis and Osteoarthritis, run by Korea Otsuka Pharmaceutical Co., Ltd. at 10 sites in South Korea.
Trial summary
To prove that the efficacy and safety of Mucosta® (Rebamipide) is non-inferior to those of Cytotec® (Misoprostol), in terms of prevention of NSAID-induced gastric ulcer. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis
- What is being tested?
- Rebamipide and Misoprostol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 396 participants
- Where
- 10 sitesSouth Korea
- Study dates
- Dec 2007to Mar 2010
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent after being informed of the clinical trial
- Males or females 19 years of age
- Intake of any brand of NSAIDs in more than half of daily dose for at least the previous 4 weeks.
Who cannot join
- Necessary to proceed in concomitant treatment with epileptic medications, anti-chollinergics, prokinetics, sucralfate
- Presence or history of allergic drug reaction to the following medications; rebamipide, Misoprostol, NSAIDs designated to the protocol
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Study site
Bucheon-si
Study site
Daegu
Study site
Daejeon
Study site
Gwangju
Study site
Incheon
Study site
Jeonju
Study site
Jinju
Study site
Pusan
Study site
Seoul
Study site
Suwon
About this study
Official title: A Phase III, Randomized, Double-dummy, Double Blind, Misoprostol-comparative Clinical Trial to Evaluate the Efficacy and Safety of Mucosta® Tablet in the Prevention of NSAID-induced Gastrointestinal Complications
To prove that the efficacy and safety of Mucosta® (Rebamipide) is non-inferior to those of Cytotec® (Misoprostol), in terms of prevention of NSAID-induced gastric ulcer.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis
- Being tested
- Rebamipide, Misoprostol
- Keywords
- Patients with rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis or any other arthritis-like disease requiring continuous NSAIDs therapy
- Medical subject headings
- Arthritis, Rheumatoid, Osteoarthritis, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RebamipideDrug
Also called Mucosta
Rebamipide 100㎎, 12 weeks
MisoprostolDrug
Also called Cytotec®
Misoprostol 200㎍ 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Rebamipide |
| 2 | Active comparator | Not described Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of gastric ulcer on gastroendoscopy result at 12-week
Measured: 12 weeks
Secondary outcomes (3)
Rate of Therapeutic failure
Measured: 12 weeks
Severity of gastrointestinal symptoms
Measured: 12 weeks
Antacid consumption
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 396 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Soo-Heon Park, MD PhD, Principal investigator, Catholic University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576706
- Sponsor's protocol ID
- 037-KOA-0701i
- Acronym
- PRESENT
- Status last verified
- Nov 2011
- First submitted
- 17 Dec 2007
- Last updated
- 16 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-dummy, Double Blind, Misoprostol-comparative Clinical Trial to Evaluate the Efficacy and Safety of Mucosta® Tablet in the Prevention of NSAID-induced Gastrointestinal Complications
- ClinicalTrials.gov ID
- NCT00576706
- Acronym / sponsor ID
- PRESENT / 037-KOA-0701i
- Conditions
- Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis
- Keywords
- Patients with rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis or any other arthritis-like disease requiring continuous NSAIDs therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 396 participants (estimated)
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 19 Dec 2007 (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.
To prove that the efficacy and safety of Mucosta® (Rebamipide) is non-inferior to those of Cytotec® (Misoprostol), in terms of prevention of NSAID-induced gastric ulcer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Rebamipide |
| 2 | Active comparator | Drug: Misoprostol |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed written informed consent after being informed of the clinical trial
- Males or females 19 years of age
- Intake of any brand of NSAIDs in more than half of daily dose for at least the previous 4 weeks.
Key exclusion criteria (2 listed)
- Necessary to proceed in concomitant treatment with epileptic medications, anti-chollinergics, prokinetics, sucralfate
- Presence or history of allergic drug reaction to the following medications; rebamipide, Misoprostol, NSAIDs designated to the protocol
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 |
|---|---|---|
| RebamipideAlso: MucostaRebamipide 100㎎, 12 weeks | Drug | 1 |
| MisoprostolAlso: Cytotec®Misoprostol 200㎍ 12 weeks | Drug | 2 |
Primary outcome
Incidence rate of gastric ulcer on gastroendoscopy result at 12-week
Time frame: 12 weeks
3 secondary outcomes
Rate of Therapeutic failure
Time frame: 12 weeks
Severity of gastrointestinal symptoms
Time frame: 12 weeks
Antacid consumption
Time frame: 12 weeks
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 16 Nov 2011.
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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.
Soo-Heon Park, MD PhD principal investigator
Catholic University Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rebamipide and Misoprostol in people with Rheumatoid Arthritis and Osteoarthritis, run by Korea Otsuka Pharmaceutical Co., Ltd. at 10 sites in South Korea.
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 3 inclusion and 2 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 16 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. 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. 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?
Incidence rate of gastric ulcer on gastroendoscopy result at 12-week (time frame: 12 weeks). 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 16 Nov 2011.