Study to Evaluate the Efficacy and Safety of Intra-articular DA-5202 in Patients With Osteoarthritis of the Knee
NCT ID: NCT02554240
Last Updated: 2021-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
115 participants
INTERVENTIONAL
2014-12-23
2016-10-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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DA-5202 High dose
\- DA-5202 20mg
DA-5202 20mg
once a week, intra-articular injection, for 3 weeks
DA-5202 Low dose
\- DA-5202 10mg
DA-5202 10mg
once a week, intra-articular injection, for 3 weeks
Na Hyaluronate 20mg
Na Hyaluronate 20mg
Na Hyaluronate 20mg
once a week, intra-articular injection, for 3 weeks
Interventions
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DA-5202 20mg
once a week, intra-articular injection, for 3 weeks
DA-5202 10mg
once a week, intra-articular injection, for 3 weeks
Na Hyaluronate 20mg
once a week, intra-articular injection, for 3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* primary knee osteoarthritis confirmed clinically and radiologically according to American College of Rheumatology criteria and have following 3 items
1. knee joint pain
2. have any of the following
1. males and females more than 50 y
2. morning stiffness within 30 minutes
3. crepitus
3. presence of spur on radiological evidence
* Kellgren-Lawrence Grade Ⅰ to Ⅲ confirmed radiologically
* knee pain under weight-bearing greater than 40/100mm-VAS(Visual Analogue Scale) at randomization visit
* patients willing and able to provide signed informed consent after the nature of the study has been explained
Exclusion Criteria
* complete obliteration of femoropatellar joint space on X-ray
* Kellgren-Lawrence Grade IV
* knee surgery within a year
* history of fracture, rheumatoid arthritis or other inflammatory arthritis in knee articular cavity
* intra-articular corticosteroid injection within 3 months or hyaluronate injection within 6 months
* skin diseases or infection overlying the joint
* history of severe drug allergy or hypersensitivity to drugs(piroxicam, hyaluronic acid)
* history of allergy, asthma, rhinitis, angioedema, rash to aspirin or other NSAIDs (including COX-2 inhibitor)
* treatment with anticoagulants such as heparin or coumarins (warfarin etc.)
* History of GI diseases such as peptic ulcer, bleeding, perforation, ulcerative colitis, Crohn's disease within 1 year
* severe hypertension
* patients with psychiatric disorder, alcoholism, drug addiction
* presence of severe concomitant diseases or malignancy within 5 years
* have participated in another clinical trial 4 weeks prior to the study
* women of child-bearing potential who are not using \*adequate means of contraception (\*adequate means of contraception: condom, oral contraception, barrier methods using spermicide, intrauterine devices etc.)
* any condition that, in the view of the investigator, would interfere with study participation
20 Years
80 Years
ALL
No
Sponsors
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Dong-A ST Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Myung chul Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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DA5202_KOA_II
Identifier Type: -
Identifier Source: org_study_id
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