Assessment of Protective Effect of JOINS on Cartilage in Knee Osteoarthritis (Joins_Carp_Ⅳ)
- A Pilot study
- Randomized and Double-blinded
- Placebo controlled
- In 2 parallel group (JOINS 200mg:Placebo = 1:1)
- Up to 24 months treatment
- Provide rescue medicine throughout whole clinical trial period.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||A Randomized, Double Blinded, Parallel Group, Placebo-controlled Clinical Trial to Assess the Protective Effect of JOINS on Cartilage in Knee Osteoarthritis|
- Knee MRI [ Time Frame: up to 4 times ] [ Designated as safety issue: No ]
- Knee radiography [ Time Frame: up to 4 times ] [ Designated as safety issue: No ]
- Knee pain(VAS) [ Time Frame: up to 6 times ] [ Designated as safety issue: Yes ]
- K-WOMAC [ Time Frame: up to 6 times ] [ Designated as safety issue: Yes ]
- Consumption of rescue medication [ Time Frame: up to 6 times ] [ Designated as safety issue: Yes ]The quantity of rescue medicine will be counted by investigator and recorded in official clinical research document form.
- Biomarker [ Time Frame: up to 6 times ] [ Designated as safety issue: Yes ]Patients will need to be strictly fasting from the night before the visit. The data of biological cartilage and bone markers will be collected.
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Drug: JOINS 200mg
1 tablet at each time, 3 times a day
Other Name: JOINS
|Placebo Comparator: Placebo||
placebo of Joins 200mg
Other Name: Placebo
Assessment of Efficacy
Knee MRI(Magnetic resonance imaging):
- Assessment of changes in cartilage volume, thickness and GAG(glycosaminoglycan)concentration of target knee.
- Assessment of changes in minimal medial JSW of target knee.
- 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 in the morning before 10 am, after a night fasting period to avoid the variations.
- Assessment of Safety
- Estimated Enrollment: 76
|Korea, Republic of|
|Seoul National University hospital|
|Seoul, Korea, Republic of|
|Principal Investigator:||Myoungchul Lee, PH.D..||Orthopedics, Seoul National University hospital|