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CompletedNCT01293955Joins_Carp_ⅣUpdated Apr 24, 2015

Assessment of Protective Effect of JOINS on Cartilage in Knee Osteoarthritis

A Phase 4 interventional study of JOINS 200mg and Placebo in Knee Osteoarthritis, sponsored by SK Chemicals Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 45 Years to 79 Years. Per ClinicalTrials.gov, last updated 2015-04-24.

Sponsored by SK Chemicals Co., Ltd. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
45 Years to 79 Years
Sex
All
01

Study 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.
Read the 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
02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • cartilage
  • knee osteoarthritis
  • protective effect
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.

This study's enrollment of 76 is close to the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

SK Chemicals Co., Ltd. is the lead sponsor of 53 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
76 participants (actual)

Study arms

  • 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

  • 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.

    Drug: Placebo

Interventions

  • DrugJOINS 200mg

    1 tablet at each time, 3 times a day

    Also known as: JOINS

  • DrugPlacebo

    placebo of Joins 200mg

06

What researchers measure

Primary outcomes

  1. Knee MRI

    Time frame: up to 4 times

Secondary outcomes

  1. Knee radiography

    Time frame: up to 4 times

  2. Knee pain(VAS)

    Time frame: up to 6 times

  3. K-WOMAC

    Time frame: up to 6 times

  4. Consumption of rescue medication

    The quantity of rescue medicine will be counted by investigator and recorded in official clinical research document form.

    Time frame: up to 6 times

  5. Biomarker

    Patients will need to be strictly fasting from the night before the visit. The data of biological cartilage and bone markers will be collected.

    Time frame: up to 6 times

07

Study locations

1 site
  • Seoul National University hospital
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01293955
Lead sponsor
SK Chemicals Co., Ltd.
Responsible party
Sponsor
First posted
Feb 11, 2011
Start date
Aug 2010
Primary completion
Sep 2013
Completion
Sep 2013
Last update
Apr 24, 2015

Study contacts

Myoungchul Lee, PH.D..
principal investigator · Orthopedics, Seoul National University hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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