The Efficacy and Safety of Invossa K Injection in Patients Diagnosed With Knee Osteoarthritis

NCT ID: NCT03383471

Last Updated: 2018-03-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-12
• Study Completion Date: 2020-03-30

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Invossa K Inj.

Invossa K Inj.

Group Type: EXPERIMENTAL

Invossa K Inj.

Intervention Type: BIOLOGICAL

Invossa K Inj.

Placebo

Placebo control

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo control

Interventions

Invossa K Inj.

Invossa K Inj.

Intervention Type: BIOLOGICAL

Placebo

Placebo control

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female aged 19 and older

2. Patients with IKDC Subjective Knee Evaluation of ≤ 60 of the target knee.

3. Patients with a score of ≥ 40 on the 100 mm pain VAS of the target knee.

4. Patients with grade 2 osteoarthritis as determined by the radiographic criteria of Kellgren and Lawrence

5. BMI should fall between 18.5 and 30

6. 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

7. With major lesions concentrated in one section of the knee, and with the major lesions considered the main cause of the clinical symptoms

8. Patients with persistent symptoms in spite of conservative therapy for more than 3 months : Improvement of 100 mm VAS are less than 10 mm after 3 months

9. Healthy, with no major findings from the physical examination, hematology, serum chemistry, and urine tests, and no significant medical history

10. Agreed to use an effective contraceptive method during the study period

11. Voluntarily agreed to participate in this study, and signed the informed consent form

Exclusion Criteria

1. 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)

2. Patients taking steroidal anti-inflammatory medications within 14 days of baseline visit (But, possible to include after 14 days of wash-out period)

3. Patients with severe pain in other areas that could effect the diagnosis of the symptoms

4. Patients over Grade 3 osteoarthritis as determined by the radiographic criteria of Kellgren and Lawrence

5. History of surgery like arthroendoscopy within the past 6 months on the target knee

6. Patients who had been administered with immunosuppressants, including antirheumatic drugs (including methotrexate or antimetabolite), within the past 3 months

7. History of injection within the past 3 months on the target knee

8. Pregnant or breastfeeding female

9. With another joint disease apart from degenerative arthritis

10. Patients with hepatitis including carrier

11. Patients with HIV and an infectious disease which is clinically uncontrolled

12. Patients who have any of the following clinically significant diseases or have a medical history within 6 months :

• Clinically significant heart diseases which are considered by the investigator
• Uncontrolled hypertension : if the systolic blood pressure exceeds 160 mmHg or diastolic blood pressure exceeds 100 mmHg in a sitting position
• Kidney disease
• Liver disease
• Endocrine disease
• Uncontrolled diabetes mellitus : HbA1c ≥ 9%
• Paget's disease, ochronosis, acromegaly, hemochromatosis, Wilson's disease
• Genetic diseases (hyperkinesia, collagen gene abnormality)

13. Medical history of past or current malignant tumor

14. Patients with a history of anaphylactic reactions

15. Patients with a history of hypersensitivity reactions to the components of this drug, including dimethylsulfoxide, mannitol, dextran 40 or bovine proteins

16. Participated in another clinical trial (using the investigational drug or a medical device) within 30 days before enrollment in this study

17. Patients who administered the INVOSSA K inj.

18. Considered inappropriate by the investigator for participation in this study

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kolon Life Science

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Myung-Chul Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopedic Surgery, Seoul National University Hospital

Locations

Korea University Anam Hospital

Ansan, , South Korea

Inje University Busan Paik Hospital

Busan, , South Korea

Kyungpook National University School of Medicine

Daegu, , South Korea

Chungnam National University School of Medicine

Daejeon, , South Korea

Chonnam National University Hwasun Hospital

Hwasun, , South Korea

Inha University Hospital

Incheon, , South Korea

Asan Medical Center

Seoul, , South Korea

College of Medicine, Hanyang University

Seoul, , South Korea

Ewha Womans University Mokdong Hospital

Seoul, , South Korea

Konkuk University Medical Center

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

School of Medicine, Kyung Hee University

Seoul, , South Korea

Seoul National University Borame Medical Center

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

The Catholic University of Korea College of Medicine

Seoul, , South Korea

Yonsei University School of Medicine

Seoul, , South Korea

Ajou University School of Medicine

Suwon, , South Korea

Countries

South Korea

Other Identifiers

KS-INV-02-3

Identifier Type: -

Identifier Source: org_study_id