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)
- 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
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 Name: JOINS
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.
placebo of Joins 200mg
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
- Assessment of changes in minimal medial JSW(Joint Space Width) 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01293955
|Korea, Republic of|
|Seoul National University hospital|
|Seoul, Korea, Republic of|
|Principal Investigator:||Myoungchul Lee, PH.D..||Orthopedics, Seoul National University hospital|