PelubiprofenPhase 3NCT01781702
Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. in Rheumatoid Arthritis Patients
A Phase 3 study testing Pelubiprofen 30 mg and Celebrex 200 mg in people with Pelubiprofen and Celebrex, run by Daewon Pharmaceutical Co., Ltd..
Trial summary
A Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. \& Celebrex Cap. for Comparative Evaluation of Safety \& Efficacy in Rheumatoid Arthritis Patients Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pelubiprofen, Celebrex, Rheumatoid Arthritis
- What is being tested?
- Pelubiprofen 30 mg and Celebrex 200 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Oct 2011
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males/Females aged 18~80 years
- Patient who are taking NSAIDs for the treatment of rheumatoid arthritis
- Patients who belong to ACR functional class 1, 2, 3
Who cannot join
- Patients who belong to ACR functional class 4
- Patients who are hypersensitive to clinical trial medicines or excipient
- Patients who have experience of Cerebrovascular bleeding, bleeding disorder
About this study
Official title: A Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. for Comparative Evaluation of Safety & Efficacy in Rheumatoid Arthritis Patients
A Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. \& Celebrex Cap. for Comparative Evaluation of Safety \& Efficacy in Rheumatoid Arthritis Patients
- Conditions
- Pelubiprofen, Celebrex, Rheumatoid Arthritis
- Being tested
- Pelubiprofen 30 mg, Celebrex 200 mg
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelubiprofen 30 mgDrug
Celebrex 200 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Pelubiprofen 30 mg | Experimental | Pelubiprofen 30 mg, tid Receives: Drug: Pelubiprofen 30 mg |
| Celebrex 200 mg | Active comparator | Celebrex 200 mg, tid Receives: Drug: Celebrex 200 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in '100 mm pain VAS' value from baseline
Measured: -14, 0, 14, 28, 42 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startOct 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PelubiprofenStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781702
- Sponsor's protocol ID
- DW Plb RA301
- Status last verified
- Aug 2013
- First submitted
- 30 Jan 2013
- Last updated
- 9 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Choi IA, Baek HJ, Cho CS, Lee YA, Chung WT, Park YE, Lee YJ, Park YB, Lee J, Lee SS, Yoo WH, Song JS, Kang SW, Kim HA, Song YW. Comparison of the efficacy and safety profiles of a pelubiprofen versus celecoxib in patients with rheumatoid arthritis: a 6-week, multicenter, randomized, double-blind, phase III, non-inferiority clinical trial. BMC Musculoskelet Disord. 2014 Nov 18;15:375. doi: 10.1186/1471-2474-15-375.
PubMed 25403311
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. for Comparative Evaluation of Safety & Efficacy in Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT01781702
- Acronym / sponsor ID
- DW Plb RA301
- Conditions
- Pelubiprofen, Celebrex, Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 1 Feb 2013 (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.
A Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. \& Celebrex Cap. for Comparative Evaluation of Safety \& Efficacy in Rheumatoid Arthritis Patients
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelubiprofen 30 mg | Experimental | Drug: Pelubiprofen 30 mgPelubiprofen 30 mg, tid |
| Celebrex 200 mg | Active comparator | Drug: Celebrex 200 mgCelebrex 200 mg, tid |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult males/Females aged 18~80 years
- Patient who are taking NSAIDs for the treatment of rheumatoid arthritis
- Patients who belong to ACR functional class 1, 2, 3
Key exclusion criteria (3 listed)
- Patients who belong to ACR functional class 4
- Patients who are hypersensitive to clinical trial medicines or excipient
- Patients who have experience of Cerebrovascular bleeding, bleeding disorder
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 |
|---|---|---|
| Pelubiprofen 30 mg | Drug | Pelubiprofen 30 mg |
| Celebrex 200 mg | Drug | Celebrex 200 mg |
Primary outcome
Changes in '100 mm pain VAS' value from baseline
Time frame: -14, 0, 14, 28, 42 day
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 9 Aug 2013.
- Derived from this study: PubMed 25403311Choi IA, Baek HJ, Cho CS, Lee YA, Chung WT, Park YE, Lee YJ, Park YB, Lee J, Lee SS, Yoo WH, Song JS, Kang SW, Kim HA, Song YW. Comparison of the efficacy and safety profiles of a pelubiprofen versus celecoxib in patients with rheumatoid arthritis: a 6-week, multicenter, randomized, double-blind, phase III, non-inferiority clinical trial. BMC Musculoskelet Disord. 2014 Nov 18;15:375. doi: 10.1186/1471-2474-15-375.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pelubiprofen 30 mg and Celebrex 200 mg in people with Pelubiprofen and Celebrex, run by Daewon Pharmaceutical Co., Ltd..
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 3 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 9 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Changes in '100 mm pain VAS' value from baseline (time frame: -14, 0, 14, 28, 42 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01781702, which also lists 1 linked publication.
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 9 Aug 2013.