Osteoarthritis of the KneePhase 4NCT01768468
To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients
A Phase 4 study testing LAYLA tablet and JOINS tablet in people with Osteoarthritis of the Knee, run by PMG Pharm Co., Ltd at 6 sites in South Korea.
Trial summary
This is a randomized, double-blind study to compare the efficacy and safety of LAYLA tablet and Joins tablet in the treatment of osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- LAYLA tablet and JOINS tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 6 sitesSouth Korea
- Study dates
- Oct 2012to Sep 2013
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥40 and ≤ 80years of age
- Radiographic evidence of grade 2 or 3 osteoarthritis based on the Kellgren \& Lawrene radiographic entry criteria
- Stable osteoarthritis during 3 months
- Score of 100mm pain VAS ≤ 80mm at screening
- Score of 100mm pain VAS ≥ 50mm at baseline
- Written consent form voluntarily
Who cannot join
- Disease of spine or other Lower limb joints that could affect to evaluate the efficacy
- History of surgery or arthroscopy of the study joint within 6 months
- Trauma of study joint within 12 months
- Medication of constantly(more than 1 week) corticosteroid by oral within 3 months
- Medication of intra-articular injection within 3 months
- Diagnosed with psychical disorder, and taking medication
Show all 15Show fewer
- History of upper gastrointestinal ulceration within 6 months
- History of upper gastrointestinal bleeding within 12 months
- Serum creatinine, ALT, AST, total bilirubin over UNL X 2.0 at screening test
- History of hypersensitivity to LAYLA, JOINS, or NSAIDs
- Participation in another clinical trials within 4 weeks
- Medication of constantly (more than 1 week) narcotic analgesics within 3 months
- Not consent about using effectual contraception method during trial
- Pregnant or lactating woman
- Investigator's judgment
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Keimyug University Dongsan Medical Center
Daegu
Hanyang University Guri Hospital
Seoul
Korea University Anam Hospital
Seoul
Samsung Medical Center
Seoul
SMG-SNU Boramae Medical Center
Seoul
Ajou University Hospital
Suwon
About this study
Official title: Double Blinded, Randomized, Active Drug Comparative, Multi-center, Phase IV Clinical Study to Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients
This is a randomized, double-blind study to compare the efficacy and safety of LAYLA tablet and Joins tablet in the treatment of osteoarthritis of the knee.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- LAYLA tablet, JOINS tablet
- Keywords
- LAYLA, Non-inferiority, 100mm pain VAS
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAYLA tabletDrug
Also called LAYLA 405.4mg
1 tablet twice a day
JOINS tabletDrug
Also called JOINS 200mg
1 tablet at each time, 3 times a day
| Study group | Role | What they receive |
|---|---|---|
| LAYLA | Experimental | Drug : LAYLA tablet/ bid Receives: Drug: LAYLA tablet |
| JOINS | Active comparator | Drug : JOINS tablet/ tid Receives: Drug: JOINS tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 100mm Pain VAS
Measured: baseline throgh week 8
Secondary outcomes (6)
Change from baseline in 100mm pain VAS
Measured: 12 weeks
Change rate from baseline in 100mm Pain VAS
Measured: 8 weeks, 12 weeks
Change from baseline in WOMAC
Measured: 8 weeks, 12 weeks
Change from baseline in EQ-5D
Measured: 8 weeks, 12 weeks
Change in the patient self-assessed & investigator-assessed overall symptom score
Measured: 8 weeks, 12 weeks
Consumption of rescue medication
Measured: 4 times
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionJun 2013
- Study completionSep 2013
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 Osteoarthritis of the 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- PMG Pharm Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ye Soo Park, Principal investigator, Hanyang University Guri HospitalChul Won Ha, Principal investigator, Samsung Medical CenterYe Yeon Won, Principal investigator, Ajou University School of MedicineJae Hyup Lee, Principal investigator, SMG-SNU Boramae Medical CenterByung Woo Min, Principal investigator, Keimyug University Dongsan Medical CenterSeung Beom Han, Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768468
- Sponsor's protocol ID
- LAYLA-P4
- Status last verified
- Oct 2013
- First submitted
- 11 Jan 2013
- Last updated
- 14 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ha CW, Park YB, Min BW, Han SB, Lee JH, Won YY, Park YS. Prospective, randomized, double-blinded, double-dummy and multicenter phase IV clinical study comparing the efficacy and safety of PG201 (Layla) and SKI306X in patients with osteoarthritis. J Ethnopharmacol. 2016 Apr 2;181:1-7. doi: 10.1016/j.jep.2016.01.029. Epub 2016 Jan 25.
PubMed 26821189
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blinded, Randomized, Active Drug Comparative, Multi-center, Phase IV Clinical Study to Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT01768468
- Acronym / sponsor ID
- LAYLA-P4
- Conditions
- Osteoarthritis of the Knee
- Keywords
- LAYLA, Non-inferiority, 100mm pain VAS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- PMG Pharm Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 15 Jan 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.
This is a randomized, double-blind study to compare the efficacy and safety of LAYLA tablet and Joins tablet in the treatment of osteoarthritis of the knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LAYLA | Experimental | Drug: LAYLA tabletDrug : LAYLA tablet/ bid |
| JOINS | Active comparator | Drug: JOINS tabletDrug : JOINS tablet/ tid |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients ≥40 and ≤ 80years of age
- Radiographic evidence of grade 2 or 3 osteoarthritis based on the Kellgren \& Lawrene radiographic entry criteria
- Stable osteoarthritis during 3 months
- Score of 100mm pain VAS ≤ 80mm at screening
- Score of 100mm pain VAS ≥ 50mm at baseline
Key exclusion criteria (15 listed)
- Disease of spine or other Lower limb joints that could affect to evaluate the efficacy
- History of surgery or arthroscopy of the study joint within 6 months
- Trauma of study joint within 12 months
- Medication of constantly(more than 1 week) corticosteroid by oral within 3 months
- Medication of intra-articular injection within 3 months
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 |
|---|---|---|
| LAYLA tabletAlso: LAYLA 405.4mg1 tablet twice a day | Drug | LAYLA |
| JOINS tabletAlso: JOINS 200mg1 tablet at each time, 3 times a day | Drug | JOINS |
Primary outcome
Change in 100mm Pain VAS
Time frame: baseline throgh week 8
6 secondary outcomes
Change from baseline in 100mm pain VAS
Time frame: 12 weeks
Change rate from baseline in 100mm Pain VAS
Time frame: 8 weeks, 12 weeks
Change from baseline in WOMAC
Time frame: 8 weeks, 12 weeks
Change from baseline in EQ-5D
Time frame: 8 weeks, 12 weeks
Change in the patient self-assessed & investigator-assessed overall symptom score
Time frame: 8 weeks, 12 weeks
Consumption of rescue medication
Time frame: 4 times
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 14 Oct 2013.
- Derived from this study: PubMed 26821189Ha CW, Park YB, Min BW, Han SB, Lee JH, Won YY, Park YS. Prospective, randomized, double-blinded, double-dummy and multicenter phase IV clinical study comparing the efficacy and safety of PG201 (Layla) and SKI306X in patients with osteoarthritis. J Ethnopharmacol. 2016 Apr 2;181:1-7. doi: 10.1016/j.jep.2016.01.029. Epub 2016 Jan 25.
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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.
Ye Soo Park principal investigator
Hanyang University Guri Hospital
Chul Won Ha principal investigator
Samsung Medical Center
Ye Yeon Won principal investigator
Ajou University School of Medicine
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing LAYLA tablet and JOINS tablet in people with Osteoarthritis of the Knee, run by PMG Pharm Co., Ltd at 6 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 6 inclusion and 15 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 14 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 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 in 100mm Pain VAS (time frame: baseline throgh week 8). 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 NCT01768468, 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 14 Oct 2013.