NCT01293955

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P25-P50 for phase_4 knee-osteoarthritis

Timeline
Completed

Started Aug 2010

Longer than P75 for phase_4 knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 11, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

April 24, 2015

Status Verified

April 1, 2015

Enrollment Period

3.1 years

First QC Date

November 23, 2010

Last Update Submit

April 23, 2015

Conditions

Knee Osteoarthritis

Keywords

cartilageknee osteoarthritisprotective effect

Outcome Measures

Primary Outcomes (1)

  • Knee MRI

    up to 4 times

Secondary Outcomes (5)

  • Knee radiography

    up to 4 times

  • Knee pain(VAS)

    up to 6 times

  • K-WOMAC

    up to 6 times

  • Consumption of rescue medication

    up to 6 times

  • Biomarker

    up to 6 times

Study Arms (2)

JOINS 200mg

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

JOINS 200mgDRUG

1 tablet at each time, 3 times a day

Also known as: JOINS
JOINS 200mg
PlaceboDRUG

placebo of Joins 200mg

Placebo

Eligibility Criteria

Age45 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Myoungchul Lee, PH.D..

    Orthopedics, Seoul National University hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2010

First Posted

February 11, 2011

Study Start

August 1, 2010

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

April 24, 2015

Record last verified: 2015-04

Locations

KR(1)