Assessment of Protective Effect of JOINS on Cartilage in Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

— Joins_Carp_?  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293955
• Other study ID #: Joins_Carp_IV_2009
• Status: Completed
• Phase: Phase 4
• First received: November 23, 2010
• Last updated: April 23, 2015
• Start date: August 2010
• Est. completion date: September 2013

Study information

• Verified date: April 2015
• Source: SK Chemicals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 79 Years

Eligibility

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 (? age > 50 years, morning stiffness < 30 minute, ? 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.

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

Intervention

Drug:
• JOINS 200mg
1 tablet at each time, 3 times a day
• Placebo
placebo of Joins 200mg

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
SK Chemicals Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee MRI		up to 4 times	No
Secondary	Knee radiography		up to 4 times	No
Secondary	Knee pain(VAS)		up to 6 times	Yes
Secondary	K-WOMAC		up to 6 times	Yes
Secondary	Consumption of rescue medication	The quantity of rescue medicine will be counted by investigator and recorded in official clinical research document form.	up to 6 times	Yes
Secondary	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.	up to 6 times	Yes