Osteoarthritis of KneePhase 4NCT02682524
Phase IV Clinical Trial to Evaluate the Efficacy and Safety of PlbCR and Aceclofenac in the Treatment of Patients With Osteoarthritis of the Knee
A Phase 4 study testing Pelubiprofen CR 45mg tab. and Aceclofenac 100mg tab. in people with Osteoarthritis of Knee, run by Daewon Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
A multicenter, randomized, double-blinded, parallel, active-controlled, phase IV clinical trial to evaluate the efficacy and safety of PlbCR and aceclofenac in the treatment of patients with osteoarthritis of the knee Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Osteoarthritis of Knee
- What is being tested?
- Pelubiprofen CR 45mg tab. and Aceclofenac 100mg tab.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2015to Mar 2016
- Phase
- Phase 4
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- both male and female who is over 35year-old and below 80year-old
- patient who diagnosed as Kellgren \& Lawrence stage I~III by X-ray
- osteoarthritis patient who is stable within 3months form starting this clinical trial
- patient who is over 40mm in 100mm Pain VAS at Visit 2
- patient who agreed to participate this clinical trial spontaneously
Who cannot join
- second osteoarthritis
- patient who has inflammatory disease which can effect efficacy outcomes such as bursitis, tenosynovitis, rheumatoid arthritis, etc.
- patient who diagnosed as gastric ulcer or GI disease by esophagogastroduodenoscopy
- patient who had joint surgery within 12months form screening visit of this clinical trial or planned to operate in this clinical trial period
- patient who has had artificial joint surgery of knee
- malignant tumor patient
Show all 19Show fewer
- patient who has taken Psychopharmaceutical or Narcotic Analgesics over 3months continuously
- patient who took steroid by oral, inhalation or intraarticular injection within 3months form screening visit of this clinical trial
- patient who took intraarticular hyaluronic acid injection of knee within 2months form screening visit of this clinical trial
- patient who cannot take NSAIDs because of disease or medicine
- allergy of aspirin of other NSAIDs
- patient who has to handle his/her pain by or for CABG
- galactose intolerance, Lactose Intolerance or glucose-galactose malabsorption
- inflammatory bowel disease such as ulcerative colitis or Crohn's disease
- moderate renal disease
- moderate hepatic disease
- moderate hypertension(SBP=>160mmHg, DBP=>100mmHg)
- female who consents to contracept
- patient who is not appropriate for this clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
A multicenter, randomized, double-blinded, parallel, active-controlled, phase IV clinical trial to evaluate the efficacy and safety of PlbCR and aceclofenac in the treatment of patients with osteoarthritis of the knee
- Conditions
- Osteoarthritis of Knee
- Being tested
- Pelubiprofen CR 45mg tab., Aceclofenac 100mg tab.
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelubiprofen CR 45mg tab.Drug
Aceclofenac 100mg tab.Drug
| Study group | Role | What they receive |
|---|---|---|
| test | Active comparator | Not described Receives: Drug: Pelubiprofen CR 45mg tab. |
| reference | Active comparator | Not described Receives: Drug: Aceclofenac 100mg tab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline 100mm Pain VAS at 4weeks
Measured: 4weeks
Secondary outcomes (3)
Change from baseline 100mm Pain VAS at 2weeks
Measured: 2weeks
Change from baseline K-WOMAC Scale at 2weeks and 4weeks
Measured: 2weeks, 4weeks
Patient Global Assessment
Measured: 4weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study startAug 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of KneeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 191 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
- NCT02682524
- Sponsor's protocol ID
- DW_PlbCR_401
- Status last verified
- Oct 2016
- First submitted
- 12 Oct 2015
- Last updated
- 10 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Clinical Trial to Evaluate the Efficacy and Safety of PlbCR and Aceclofenac in the Treatment of Patients With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT02682524
- Acronym / sponsor ID
- DW_PlbCR_401
- Conditions
- Osteoarthritis of Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 15 Feb 2016 (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 multicenter, randomized, double-blinded, parallel, active-controlled, phase IV clinical trial to evaluate the efficacy and safety of PlbCR and aceclofenac in the treatment of patients with osteoarthritis of the knee
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test | Active comparator | Drug: Pelubiprofen CR 45mg tab. |
| reference | Active comparator | Drug: Aceclofenac 100mg tab. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- both male and female who is over 35year-old and below 80year-old
- patient who diagnosed as Kellgren \& Lawrence stage I~III by X-ray
- osteoarthritis patient who is stable within 3months form starting this clinical trial
- patient who is over 40mm in 100mm Pain VAS at Visit 2
- patient who agreed to participate this clinical trial spontaneously
Key exclusion criteria (19 listed)
- second osteoarthritis
- patient who has inflammatory disease which can effect efficacy outcomes such as bursitis, tenosynovitis, rheumatoid arthritis, etc.
- patient who diagnosed as gastric ulcer or GI disease by esophagogastroduodenoscopy
- patient who had joint surgery within 12months form screening visit of this clinical trial or planned to operate in this clinical trial period
- patient who has had artificial joint surgery of knee
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 CR 45mg tab. | Drug | test |
| Aceclofenac 100mg tab. | Drug | reference |
Primary outcome
Change from baseline 100mm Pain VAS at 4weeks
Time frame: 4weeks
3 secondary outcomes
Change from baseline 100mm Pain VAS at 2weeks
Time frame: 2weeks
Change from baseline K-WOMAC Scale at 2weeks and 4weeks
Time frame: 2weeks, 4weeks
Patient Global Assessment
Time frame: 4weeks
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 10 Oct 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pelubiprofen CR 45mg tab. and Aceclofenac 100mg tab. in people with Osteoarthritis of Knee, run by Daewon Pharmaceutical Co., Ltd. at 1 site 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 5 inclusion and 19 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 10 Oct 2016. 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 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change from baseline 100mm Pain VAS at 4weeks (time frame: 4weeks). 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 10 Oct 2016.