Assessment of Protective Effect of JOINS on Cartilage in Knee Osteoarthritis (Joins_Carp_Ⅳ)
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|ClinicalTrials.gov Identifier: NCT01293955|
Recruitment Status : Completed
First Posted : February 11, 2011
Last Update Posted : April 24, 2015
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Drug: JOINS 200mg Drug: Placebo||Phase 4|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double Blinded, Parallel Group, Placebo-controlled Clinical Trial to Assess the Protective Effect of JOINS on Cartilage in Knee Osteoarthritis|
|Study Start Date :||August 2010|
|Primary Completion Date :||September 2013|
|Study Completion Date :||September 2013|
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
- Knee MRI [ Time Frame: up to 4 times ]
- 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 ]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 ]Patients will need to be strictly fasting from the night before the visit. The data of biological cartilage and bone markers will be collected.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01293955
|Korea, Republic of|
|Seoul National University hospital|
|Seoul, Korea, Republic of|
|Principal Investigator:||Myoungchul Lee, PH.D..||Orthopedics, Seoul National University hospital|