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Assessment of Protective Effect of JOINS on Cartilage in Knee Osteoarthritis (Joins_Carp_Ⅳ)

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
JOINS 200mg
Placebo
Sponsored by
SK Chemicals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring cartilage, knee osteoarthritis, protective effect

Eligibility Criteria

45 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Seoul National University hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

JOINS 200mg

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Knee MRI

Secondary Outcome Measures

Knee radiography
Knee pain(VAS)
K-WOMAC
Consumption of rescue medication
The quantity of rescue medicine will be counted by investigator and recorded in official clinical research document form.
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.

Full Information

First Posted
November 23, 2010
Last Updated
April 23, 2015
Sponsor
SK Chemicals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01293955
Brief Title
Assessment of Protective Effect of JOINS on Cartilage in Knee Osteoarthritis
Acronym
Joins_Carp_Ⅳ
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

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SK Chemicals Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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 Knee radiography: Assessment of changes in minimal medial JSW(Joint Space Width) of target knee. Knee pain(VAS) 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
cartilage, knee osteoarthritis, protective effect

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
JOINS 200mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
JOINS 200mg
Other Intervention Name(s)
JOINS
Intervention Description
1 tablet at each time, 3 times a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo of Joins 200mg
Primary Outcome Measure Information:
Title
Knee MRI
Time Frame
up to 4 times
Secondary Outcome Measure Information:
Title
Knee radiography
Time Frame
up to 4 times
Title
Knee pain(VAS)
Time Frame
up to 6 times
Title
K-WOMAC
Time Frame
up to 6 times
Title
Consumption of rescue medication
Description
The quantity of rescue medicine will be counted by investigator and recorded in official clinical research document form.
Time Frame
up to 6 times
Title
Biomarker
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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) Appropriately signed and dated informed consent has been obtained Exclusion Criteria: Rheumatoid arthritis or inflammatory arthritis. Bilateral total knee replacement already treated, or planning for the procedure. Knee prosthesis already implanted, or foreseen within the next year. Clinically significant hip osteoarthritis. Severe renal insufficiency defined as creatinine clearance < 30ml/mln(Cockcroft formula). 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.). 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,. Allergic reaction to Clinical trial medication. Other clinical trial drugs during the 1 month prior to the screening visit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myoungchul Lee, PH.D..
Organizational Affiliation
Orthopedics, Seoul National University hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Assessment of Protective Effect of JOINS on Cartilage in Knee Osteoarthritis

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