Osteoarthritis of the KneePhase 4NCT02049606
To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients of the Knee
A Phase 4 study testing LAYLA tablet and CENATONE 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 CENATONE 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 CENATONE tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 24 Feb 2014to 30 May 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥40 and ≤80 years of age
- Radiographic evidence of grade 1,2 or 3 osteoarthritis based on the Kellgren \& Lawrence radiographic entry criteria
- Stable osteoarthritis during 3 months
- Score of 100mm Pain VAS ≤ 80mm at screening
- Score of 100mm Pain VAS ≥ 40mm at baseline
- Written consent form voluntarily
Who cannot join
- Disease of spine or other Lower limb joints that could affect fo 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
- Diagnosed with psychical disorder, and taking medication
- Medication of intra-articular injection within 3 months
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- Uncontrollable Hypertension patients at screening test
- History of upper gastrointestinal ulceration within 6 months, History of upper gastrointestinal bleeding within 12 months
- History of lower gastrointestinal bleeding within 12 months
- History of coronary artery bypass, systemic lupus erythematosus or mixed connective tissue disease
- Serum creatinine, ALT, AST, total bilirubin over ULN X 2.0 at screening test
- History of hypersensitivity of LAYLA, CENATONE 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
- History of malignant tumor within 5 years
- Investigator's judgment
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Asan Medical Center
Seoul
Chung-Ang University Hospital
Seoul
Inje University Seoul Paik Hospital
Seoul
Seoul National University Hospital
Seoul
SMG-SNU Boramae Medical Center
Seoul
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul
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 of the Knee.
This is a randomized, double-blind study to compare the efficacy and safety of LAYLA tablet and CENATONE tablet in the treatment of osteoarthritis of the knee.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- LAYLA tablet, CENATONE 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
CENATONE tabletDrug
Also called Nabumetone 500mg
2 Tablets once a day
| Study group | Role | What they receive |
|---|---|---|
| LAYLA | Experimental | Drug : LAYLA tablet/bid Receives: Drug: LAYLA tablet |
| CENATONE | Active comparator | Drug : CENATONE tablet/qd Receives: Drug: CENATONE tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from the baseline in 100mm Pain VAS
Measured: Baseline through week8
Secondary outcomes (4)
Changes rate from the baseline in 100mm Pain VAS
Measured: 8 weeks
Changes from the baseline in WOMAC
Measured: 8 Weeks
Changes from the baseline in EQ-5D
Measured: 8 Weeks
Changes in the patient self-assessed overall symptom score
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study start24 Feb 2014
- Primary completion11 May 2015
- Study completion30 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- PMG Pharm Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seung Baik Kang, MD, Principal investigator, SMG-SNU Boramae Medical CenterJeong Ku Ha, MD, Principal investigator, Inje UniversityHan Jun Lee, MD, Principal investigator, Chung-Ang University HospitalYong In, MD, Principal investigator, The Catholic University of KoreaJong Min Kim, MD, Principal investigator, Asan Medical CenterSahng Hoon Lee, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049606
- Sponsor's protocol ID
- LAYLA_P4_NB
- Status last verified
- Sep 2017
- First submitted
- 28 Jan 2014
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. 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 of the Knee.
- ClinicalTrials.gov ID
- NCT02049606
- Acronym / sponsor ID
- LAYLA_P4_NB
- Conditions
- Osteoarthritis of the Knee
- Keywords
- LAYLA, Non-inferiority, 100mm pain VAS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- PMG Pharm Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2014 (actual)
- Primary completion
- 11 May 2015 (actual)
- Study completion
- 30 May 2016 (actual)
- First posted
- 30 Jan 2014 (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 CENATONE 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 |
| CENATONE | Active comparator | Drug: CENATONE tabletDrug : CENATONE tablet/qd |
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 ≤80 years of age
- Radiographic evidence of grade 1,2 or 3 osteoarthritis based on the Kellgren \& Lawrence radiographic entry criteria
- Stable osteoarthritis during 3 months
- Score of 100mm Pain VAS ≤ 80mm at screening
- Score of 100mm Pain VAS ≥ 40mm at baseline
Key exclusion criteria (18 listed)
- Disease of spine or other Lower limb joints that could affect fo 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
- Diagnosed with psychical disorder, and taking medication
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 |
| CENATONE tabletAlso: Nabumetone 500mg2 Tablets once a day | Drug | CENATONE |
Primary outcome
Changes from the baseline in 100mm Pain VAS
Time frame: Baseline through week8
4 secondary outcomes
Changes rate from the baseline in 100mm Pain VAS
Time frame: 8 weeks
Changes from the baseline in WOMAC
Time frame: 8 Weeks
Changes from the baseline in EQ-5D
Time frame: 8 Weeks
Changes in the patient self-assessed overall symptom score
Time frame: 8 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 20 Sep 2017.
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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.
Seung Baik Kang, MD principal investigator
SMG-SNU Boramae Medical Center
Jeong Ku Ha, MD principal investigator
Inje University
Han Jun Lee, MD principal investigator
Chung-Ang University Hospital
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 CENATONE 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 18 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 20 Sep 2017. 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?
Changes from the baseline in 100mm Pain VAS (time frame: Baseline through week8). 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 20 Sep 2017.