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A Post Marketing Surveillance Study of INVOSSA K Inj.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03412864
Recruitment Status : Active, not recruiting
First Posted : January 29, 2018
Last Update Posted : May 28, 2019
Sponsor:
Information provided by (Responsible Party):
Kolon Life Science

Brief Summary:
This study is post-marketing surveillance of Invossa K injection in patients with osteoarthritis.

Condition or disease
Osteoarthritis

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post Marketing Surveillance on Safety and Effectiveness Evaluation of INVOSSA K Inj.
Actual Study Start Date : July 12, 2017
Estimated Primary Completion Date : July 11, 2023
Estimated Study Completion Date : July 11, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis




Primary Outcome Measures :
  1. AEs (Adverse Events) [ Time Frame: 0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3) ]
    Changes of incidence rate in AEs


Secondary Outcome Measures :
  1. 100 mm VAS (Visual Analog Scale) [ Time Frame: 0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3) ]
    Changes of 100 mm VAS at each visit (Scale : 0~100, 0 : No pain, 100 : Worst imaginable pain)

  2. Physical examination (Knee joint swelling) [ Time Frame: 0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3) ]
    Changes of Knee joint swelling at each visit

  3. Physical examination (Tenderness) [ Time Frame: 0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3) ]
    Changes of tenderness at each visit

  4. Physical examination (ROM) [ Time Frame: 0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3) ]
    Changes of ROM(Range Of Motion) at each visit

  5. General efficacy evaluation [ Time Frame: 6 Months(visit 3) ]
    General efficacy evaluation was assessed by following 4 criteria. (Improved, Not changed, Worsened, Unassessable)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Male or female patients over 19 years with osteoarthritis
Criteria

Inclusion Criteria:

  1. Male or female patients over 19 years
  2. Patients who diagnosed with osteoarthritis will plan to INVOSSA K Inj. injection and suitable for following criteria :

    - Moderate knee osteoarthritis (Kellgren & Lawrence grade 3) with persistent symptoms (pain, etc.) in spite of conservative therapy (medication, physical therapy, etc.) for more than 3 months

  3. Patients (or substitute) who is provided all information regarding participation of this PMS signed the informed consent form

Exclusion Criteria:

  1. Pregnant or breastfeeding female
  2. Patients who have administered corticosteroid before INVOSSA K Inj. injection within the past 30 days
  3. Patients who have severe disease such as heart, liver, kidney disease or other severe complications
  4. Patients who rheumatoid arthritis, gouty arthritis, autoimmune disease associated arthritis except for osteoarthritis
  5. Patients with a medical history of allergic diseases or patients with a medical history of anaphylactic reactions (including patients with a history of hypersensitivity reactions to the components of this drug, including dimethylsulfoxide (DMSO), mannitol, dextran 40 or bovine proteins)
  6. Patients who have been treated with injections to the target knee within the past three months or patients with a past history of surgery, including arthroscope, within the past six months
  7. Patients currently with leukemia or malignant tumors such as osteochondroma, chondroblastoma, cartilaginous mucinous fibrous tumor, chondroma and chondrosarcoma, which may be exacerbated by administration of INVOSSA-K inj. or patients with a history thereof
  8. Patients with Kellgran & Lawrence grade 4 osteoarthritis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03412864


Locations
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Korea, Republic of
Yeungnam University Hospital
Daegu, Gyeongsangbuk-do, Korea, Republic of, 42415
Sponsors and Collaborators
Kolon Life Science
Investigators
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Principal Investigator: Oog Jin Shon, MD, PhD. Yeungnam University Hospital
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Responsible Party: Kolon Life Science
ClinicalTrials.gov Identifier: NCT03412864    
Other Study ID Numbers: KS-INVOSSA-PMS
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: May 28, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kolon Life Science:
chondrocyte cells
osteoarthritis
gene therapy
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases