A Multicenter, Randomized, Placebo Controlled, Double-blind, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Invossa K Injection in Patients Diagnosed as Knee Osteoarthritis With Kellgren & Lawrence Grade 2

Kolon Life Science17 sites in 1 country146 target enrollmentFebruary 12, 2018

ConditionsOsteoarthritis

InterventionsInvossa K Inj.Placebo

DrugsPlacebo

Overview

Phase: Phase 3
Intervention: Invossa K Inj.
Conditions: Osteoarthritis
Sponsor: Kolon Life Science
Enrollment: 146
Locations: 17
Primary Endpoint: IKDC (International knee documentation committee) Subjective Knee Evaluation
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of intraarticular Invossa K Injection patients diagnosed with Kellgren & Lawrence grade 2 knee osteoarthritis.

Registry

clinicaltrials.gov

Start Date

February 12, 2018

End Date

March 30, 2020

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kolon Life Science

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female aged 19 and older
•Patients with IKDC Subjective Knee Evaluation of ≤ 60 of the target knee.
•Patients with a score of ≥ 40 on the 100 mm pain VAS of the target knee.
•Patients with grade 2 osteoarthritis as determined by the radiographic criteria of Kellgren and Lawrence
•BMI should fall between 18.5 and 30
•Patients who satisfies the clinical/radiational criteria by the American College of Rheumatology guidelines, and applies to one of the following.
•Age \> 50 years old
•Morning stiffness \< 30 minutes
•Crepitus and Osteophytes
•With major lesions concentrated in one section of the knee, and with the major lesions considered the main cause of the clinical symptoms

Exclusion Criteria

•Patients who had been administered with drugs such as oriental medicine, glucosamine and chondroitin within 14 days of baseline visit (But, possible to include after 14 days of wash-out period)
•Patients taking steroidal anti-inflammatory medications within 14 days of baseline visit (But, possible to include after 14 days of wash-out period)
•Patients with severe pain in other areas that could effect the diagnosis of the symptoms
•Patients over Grade 3 osteoarthritis as determined by the radiographic criteria of Kellgren and Lawrence
•History of surgery like arthroendoscopy within the past 6 months on the target knee
•Patients who had been administered with immunosuppressants, including antirheumatic drugs (including methotrexate or antimetabolite), within the past 3 months
•History of injection within the past 3 months on the target knee
•Pregnant or breastfeeding female
•With another joint disease apart from degenerative arthritis
•Patients with hepatitis including carrier

Arms & Interventions

Invossa K Inj.

Intervention: Invossa K Inj.

Placebo

Placebo control

Intervention: Placebo

Outcomes

Primary Outcomes

IKDC (International knee documentation committee) Subjective Knee Evaluation

Time Frame: Week 0 and 52

Changes in IKDC Subjective Knee Evaluation (score)

100 mm VAS (Visual analogue scale)

Time Frame: Week 0 and 52

Changes in 100 mm VAS

Secondary Outcomes

IKDC Subjective Knee Evaluation(Week 0, 26 and 39)
Biomarker (CTX-I) in blood(Week 0, 26, and 52)
Rescue Medication (Frequency)(Week 0, 4, 12, 26, 39, and 52)
MRI scan(Week 0, and 52)
Rescue Medication (Dosage)(Week 0, 4, 12, 26, 39, and 52)
Drop-out rate(Week 0, 4, 12, 26, 39, and 52)
Reason of drop-out(Week 0, 4, 12, 26, 39, and 52)
100 mm VAS(Week 0, 26 and 39)
Joint Space Width(Week 0, and 52)
OMERACT-OARSI (Outcome measures in rheumatology-Osteoarthritis research society international) response rate(Week 26, 39 and 52)
Biomarker (CTX-II) in urine(Week 0, 26, and 52)
WOMAC (The Western Ontario and McMaster Universities Osteoarthritis Index) score(Week 0, 26, 39 and 52)