Knee OsteoarthritisPhase 4Joins_Carp_ⅣNCT01293955
Assessment of Protective Effect of JOINS on Cartilage in Knee Osteoarthritis
A Phase 4 study testing JOINS 200mg in people with Knee Osteoarthritis, run by SK Chemicals Co., Ltd. at 1 site in South Korea.
Trial summary
A Pilot study Randomized and Double-blinded Placebo controlled In 2 parallel group (JOINS 200mg:Placebo = 1:1) Overall 24 months treatment (JOINS:Placebo comparison up to 12 months, Additional follow-up assessment up to 24 months) Provide rescue medicine throughout whole clinical trial period. Read more about this study
- Who is it for?
- Ages 45 to 79 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- JOINS 200mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2010to 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 45 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A female is eligible if she is of:
- Non-child bearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is at least 2 year after post- menopausal
- Child bearing potential and agrees to the acceptable contraceptive methods used consistently and correctly
- Pregnancy test result of negative at screening
- Primary Knee OA(Osteoarthritis) on medial femorotibial compartment based on ACR(American College Rheumatology) Criteria.
- ACR Criteria : With Knee pain and satisfied at least 1 of 3 (① age > 50 years, morning stiffness < 30 minute, ③ Presence of Crepitus and Osteophytes on motion)
- Appropriately signed and dated informed consent has been obtained
Who cannot join
- Rheumatoid arthritis or inflammatory arthritis.
- Bilateral total knee replacement already treated, or planning for the procedure.
- Knee prosthesis already implanted, or foreseen within the next year.
- Clinically significant hip osteoarthritis.
- Severe renal insufficiency defined as creatinine clearance < 30ml/mln(Cockcroft formula).
- Clinically significant pulmonary, hepatic, renal or heart disorder or diagnosis crucial disease by investigator ( Glycosuria(Diabetes mellitus) or asthma patients are excluded from this clinical study and the patients who has a clinically significant disease are also excluded.).
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- MRI contraindications : overweight, inferior limb diameter non-fitting the knee antenna, inserted pace-maker, metallic prosthesis( if known to interfere with MRI procedure or if known to be unsafe for MRI), metallic clips, insulin pump, cytostatic pump, hearing aid, essential tremor, claustrophobia, etc,.
- Allergic reaction to Clinical trial medication.
- Other clinical trial drugs during the 1 month prior to the screening visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blinded, Parallel Group, Placebo-controlled Clinical Trial to Assess the Protective Effect of JOINS on Cartilage in Knee Osteoarthritis
- A Pilot study
- Randomized and Double-blinded
- Placebo controlled
- In 2 parallel group (JOINS 200mg:Placebo = 1:1)
- Overall 24 months treatment (JOINS:Placebo comparison up to 12 months, Additional follow-up assessment up to 24 months)
- Provide rescue medicine throughout whole clinical trial period.
Read the detailed description
- Assessment of Efficacy
- Knee MRI(Magnetic resonance imaging):
- Assessment of cartilage volume, thickness in target knee
- GAG(glycosaminoglycan) concentration of target knee
- Assessment of Whole-Organ Magnetic Resonance Imaging Score (WORMS) of target knee
- Knee radiography:
- Assessment of changes in minimal medial JSW(Joint Space Width) of target knee.
- Knee pain(VAS)
- Assessment changes of pain in target knee.
- K-WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index for Korean)
- Assessment score change for pain(5 questions), stiffness(2 questions) and physical function(17 questions).
- The questionnaire is self-administered by the patients.
- Used frequency of rescue medicine.
- Biochemical cartilage and bone markers
- Blood and urine sample will be collected all through the morning after a night fasting period since 10 pm the previous day to avoid the variations.
- Assessment of Safety
- Adverse event
- Laboratory assessment
- Vital sign
- 12-lead ECG
- Physical examination
- Enrollment: 76
- Conditions
- Knee Osteoarthritis
- Being tested
- JOINS 200mg, Placebo
- Keywords
- cartilage, knee osteoarthritis, protective effect
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JOINS 200mgDrug
Also called JOINS
1 tablet at each time, 3 times a day
PlaceboDrug
placebo of Joins 200mg
| Study group | Role | What they receive |
|---|---|---|
| JOINS 200mg | Experimental | One tablet of JOINS 200mg is administered three times a day for 1 year. The subjects who consent to participate in an extension study are treated with JOINS 200mg for another 1 year. Receives: Drug: JOINS 200mg |
| Placebo | Placebo comparator | One tablet of Placebo is administered three times a day for 1 year. The subjects who consent to participate in an extension study are treated with Placebo for another 1 year. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee MRI
Measured: up to 4 times
Secondary outcomes (5)
Knee radiography
Measured: up to 4 times
Knee pain(VAS)
Measured: up to 6 times
K-WOMAC
Measured: up to 6 times
Consumption of rescue medication
The quantity of rescue medicine will be counted by investigator and recorded in official clinical research document form.
Measured: up to 6 times
Biomarker
Patients will need to be strictly fasting from the night before the visit. The data of biological cartilage and bone markers will be collected.
Measured: up to 6 times
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startAug 2010
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Chemicals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myoungchul Lee, PH.D.., Principal investigator, Orthopedics, Seoul National University hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293955
- Sponsor's protocol ID
- Joins_Carp_IV_2009
- Acronym
- Joins_Carp_Ⅳ
- Status last verified
- Apr 2015
- First submitted
- 23 Nov 2010
- Last updated
- 24 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blinded, Parallel Group, Placebo-controlled Clinical Trial to Assess the Protective Effect of JOINS on Cartilage in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01293955
- Acronym / sponsor ID
- Joins_Carp_Ⅳ / Joins_Carp_IV_2009
- Conditions
- Knee Osteoarthritis
- Keywords
- cartilage, knee osteoarthritis, protective effect
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- SK Chemicals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 11 Feb 2011 (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 Pilot study
- Randomized and Double-blinded
- Placebo controlled
- In 2 parallel group (JOINS 200mg:Placebo = 1:1)
- Overall 24 months treatment (JOINS:Placebo comparison up to 12 months, Additional follow-up assessment up to 24 months)
- Provide rescue medicine throughout whole clinical trial period.
Detailed description
- Assessment of Efficacy
- Knee MRI(Magnetic resonance imaging):
- Assessment of cartilage volume, thickness in target knee
- GAG(glycosaminoglycan) concentration of target knee
- Assessment of Whole-Organ Magnetic Resonance Imaging Score (WORMS) of target knee
- Knee radiography:
- Assessment of changes in minimal medial JSW(Joint Space Width) of target knee.
- Knee pain(VAS)
- Assessment changes of pain in target knee.
- K-WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index for Korean)
- Assessment score change for pain(5 questions), stiffness(2 questions) and physical function(17 questions).
- The questionnaire is self-administered by the patients.
- Used frequency of rescue medicine.
- Biochemical cartilage and bone markers
- Blood and urine sample will be collected all through the morning after a night fasting period since 10 pm the previous day to avoid the variations.
- Assessment of Safety
- Adverse event
- Laboratory assessment
- Vital sign
- 12-lead ECG
- Physical examination
- Enrollment: 76
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JOINS 200mg | Experimental | Drug: JOINS 200mgOne tablet of JOINS 200mg is administered three times a day for 1 year. The subjects who consent to participate in an extension study are treated with JOINS 200mg for another 1 year. |
| Placebo | Placebo comparator | Drug: PlaceboOne tablet of Placebo is administered three times a day for 1 year. The subjects who consent to participate in an extension study are treated with Placebo for another 1 year. |
Who may qualify
- Ages
- 45 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A female is eligible if she is of:
- Primary Knee OA(Osteoarthritis) on medial femorotibial compartment based on ACR(American College Rheumatology) Criteria.
- Appropriately signed and dated informed consent has been obtained
Key exclusion criteria (9 listed)
- Rheumatoid arthritis or inflammatory arthritis.
- Bilateral total knee replacement already treated, or planning for the procedure.
- Knee prosthesis already implanted, or foreseen within the next year.
- Clinically significant hip osteoarthritis.
- Severe renal insufficiency defined as creatinine clearance < 30ml/mln(Cockcroft formula).
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 |
|---|---|---|
| JOINS 200mgAlso: JOINS1 tablet at each time, 3 times a day | Drug | JOINS 200mg |
| Placeboplacebo of Joins 200mg | Drug | Placebo |
Primary outcome
Knee MRI
Time frame: up to 4 times
5 secondary outcomes
Knee radiography
Time frame: up to 4 times
Knee pain(VAS)
Time frame: up to 6 times
K-WOMAC
Time frame: up to 6 times
Consumption of rescue medication
Time frame: up to 6 times
Biomarker
Time frame: up to 6 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 24 Apr 2015.
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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.
Myoungchul Lee, PH.D.. principal investigator
Orthopedics, Seoul National University hospital
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 JOINS 200mg in people with Knee Osteoarthritis, run by SK Chemicals 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 7 inclusion and 9 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 24 Apr 2015. 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. Some participants in this study may receive a placebo. 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?
Knee MRI (time frame: up to 4 times). 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 24 Apr 2015.