Clinical trial NCT01293955: Assessment of Protective Effect of JOINS on Cartilage in Knee Osteoarthritis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Osteoarthritis
Keywords: cartilage
knee osteoarthritis
protective effect
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-02-11
Enrollment: 76
Sex: ALL
Minimum age (years): 45
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: Inclusion Criteria:

1. A female is eligible if she is of:

   * Non-child bearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is at least 2 year after post- menopausal
   * Child bearing potential and agrees to the acceptable contraceptive methods used consistently and correctly
   * Pregnancy test result of negative at screening
2. Primary Knee OA(Osteoarthritis) on medial femorotibial compartment based on ACR(American College Rheumatology) Criteria.

   * ACR Criteria : With Knee pain and satisfied at least 1 of 3 (① age \> 50 years, morning stiffness \< 30 minute, ③ Presence of Crepitus and Osteophytes on motion)
3. Appropriately signed and dated informed consent has been obtained

Exclusion Criteria:

1. Rheumatoid arthritis or inflammatory arthritis.
2. Bilateral total knee replacement already treated, or planning for the procedure.
3. Knee prosthesis already implanted, or foreseen within the next year.
4. Clinically significant hip osteoarthritis.
5. Severe renal insufficiency defined as creatinine clearance \< 30ml/mln(Cockcroft formula).
6. Clinically significant pulmonary, hepatic, renal or heart disorder or diagnosis crucial disease by investigator ( Glycosuria(Diabetes mellitus) or asthma patients are excluded from this clinical study and the patients who has a clinically significant disease are also excluded.).
7. MRI contraindications : overweight, inferior limb diameter non-fitting the knee antenna, inserted pace-maker, metallic prosthesis( if known to interfere with MRI procedure or if known to be unsafe for MRI), metallic clips, insulin pump, cytostatic pump, hearing aid, essential tremor, claustrophobia, etc,.
8. Allergic reaction to Clinical trial medication.
9. Other clinical trial drugs during the 1 month prior to the screening visit.

Primary outcomes:
measure: Knee MRI
timeFrame: up to 4 times
Secondary outcomes:
measure: Knee radiography
timeFrame: up to 4 times
measure: Knee pain(VAS)
timeFrame: up to 6 times
measure: K-WOMAC
timeFrame: up to 6 times
measure: Consumption of rescue medication
timeFrame: up to 6 times
measure: Biomarker
timeFrame: up to 6 times
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University hospital
Study officials:
affiliation: Orthopedics, Seoul National University hospital
name: Myoungchul Lee, PH.D..
role: PRINCIPAL_INVESTIGATOR
References: