Assessment of Protective Effect of JOINS on Cartilage in Knee Osteoarthritis — Joins_Carp_?  

Knee Osteoarthritis Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

• NCT number: NCT01293955
• Study type: Interventional
• Source: SK Chemicals Co.,Ltd.
• Status: Completed
• Phase: Phase 4
• Start date: August 2010
• Completion date: September 2013