Joins_Carp_Ⅳ: Assessment of Protective Effect of JOINS on Cartilage in Knee Osteoarthritis
Study Details
Study Description
Brief Summary
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A Pilot study
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Randomized and Double-blinded
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Placebo controlled
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In 2 parallel group (JOINS 200mg:Placebo = 1:1)
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Overall 24 months treatment (JOINS:Placebo comparison up to 12 months, Additional follow-up assessment up to 24 months)
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Provide rescue medicine throughout whole clinical trial period.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
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Assessment of Efficacy
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Knee MRI(Magnetic resonance imaging):
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Assessment of cartilage volume, thickness in target knee
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GAG(glycosaminoglycan) concentration of target knee
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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)
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Assessment score change for pain(5 questions), stiffness(2 questions) and physical function(17 questions).
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The questionnaire is self-administered by the patients.
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Used frequency of rescue medicine.
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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.
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Assessment of Safety
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Adverse event
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Laboratory assessment
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Vital sign
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12-lead ECG
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Physical examination
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Enrollment: 76
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: JOINS 200mg 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. |
Drug: JOINS 200mg
1 tablet at each time, 3 times a day
Other Names:
|
| Placebo Comparator: Placebo 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. |
Drug: Placebo
placebo of Joins 200mg
|
Outcome Measures
Primary Outcome Measures
- Knee MRI [up to 4 times]
Secondary Outcome Measures
- Knee radiography [up to 4 times]
- Knee pain(VAS) [up to 6 times]
- K-WOMAC [up to 6 times]
- Consumption of rescue medication [up to 6 times]
The quantity of rescue medicine will be counted by investigator and recorded in official clinical research document form.
- Biomarker [up to 6 times]
Patients will need to be strictly fasting from the night before the visit. The data of biological cartilage and bone markers will be collected.
Eligibility Criteria
Criteria
Inclusion Criteria:
- A female is eligible if she is of:
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Non-child bearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is at least 2 year after post- menopausal
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Child bearing potential and agrees to the acceptable contraceptive methods used consistently and correctly
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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
Exclusion Criteria:
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Rheumatoid arthritis or inflammatory arthritis.
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Bilateral total knee replacement already treated, or planning for the procedure.
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Knee prosthesis already implanted, or foreseen within the next year.
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Clinically significant hip osteoarthritis.
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Severe renal insufficiency defined as creatinine clearance < 30ml/mln(Cockcroft formula).
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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,.
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Allergic reaction to Clinical trial medication.
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Other clinical trial drugs during the 1 month prior to the screening visit.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- SK Chemicals Co., Ltd.
Investigators
- Principal Investigator: Myoungchul Lee, PH.D.., Orthopedics, Seoul National University hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Joins_Carp_IV_2009