NCT01293955

Assessment of Protective Effect of JOINS on Cartilage in Knee Osteoarthritis

A Randomized, Double Blinded, Parallel Group, Placebo-controlled Clinical Trial to Assess the Protective Effect of JOINS on Cartilage in Knee Osteoarthritis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: SK Chemicals Co., Ltd. · Industry
• Sex: All
• Age: 45 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Detailed description

1. Assessment of Efficacy 1. 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 2. Knee radiography: * Assessment of changes in minimal medial JSW(Joint Space Width) of target knee. 3. Knee pain(VAS) * Assessment changes of pain in target knee. 4. 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. 5. Used frequency of rescue medicine. 6. 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. 2. Assessment of Safety 1. Adverse event 2. Laboratory assessment 3. Vital sign 4. 12-lead ECG 5. Physical examination 3. Enrollment: 76

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DRUG	JOINS 200mg	1 tablet at each time, 3 times a day
DRUG	Placebo	placebo of Joins 200mg

Timeline

• Start date: 2010-08-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2011-02-11
• Last updated: 2015-04-24

Locations

1 site across 1 country: South Korea