Osteoarthritis, KneePhase 2NCT02554240
Study to Evaluate the Efficacy and Safety of Intra-articular DA-5202 in Patients With Osteoarthritis of the Knee
A Phase 2 study testing DA-5202 20mg, DA-5202 10mg and Na Hyaluronate 20mg in people with Osteoarthritis, Knee, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
This Phase II clinical study is to evaluate the efficacy and safety of DA-5202 in patients with osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- DA-5202 20mg, DA-5202 10mg and Na Hyaluronate 20mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Dec 2014to 14 Oct 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male and female patients between 20 and 80 y old
- primary knee osteoarthritis confirmed clinically and radiologically according to American College of Rheumatology criteria and have following 3 items
- knee joint pain
- have any of the following
- males and females more than 50 y
- morning stiffness within 30 minutes
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- crepitus
- 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
Who cannot join
- BMI(Body Mass Index) > 32
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Active-controlled, Dose-Response, Randomized, Double-blind, Therapeutic Exploratory Clinical Trial to Evaluate the Efficacy and Safety of Intra-articular DA-5202 in Patients With Osteoarthritis of the Knee
This Phase II clinical study is to evaluate the efficacy and safety of DA-5202 in patients with osteoarthritis of the knee.
Read the detailed description
Eligible subjects are randomly assigned to receive DA-5202 high dose(20mg) or DA-5202 low dose(10mg) or Na Hyaluronate once a week intra-articular injection for 3 weeks.
- Conditions
- Osteoarthritis, Knee
- Being tested
- DA-5202 20mg, DA-5202 10mg, Na Hyaluronate 20mg
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-5202 20mgDrug
Also called DA-5202 high dose
once a week, intra-articular injection, for 3 weeks
DA-5202 10mgDrug
Also called DA-5202 low dose
once a week, intra-articular injection, for 3 weeks
Na Hyaluronate 20mgDrug
Also called Hyruan Plus®
once a week, intra-articular injection, for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| DA-5202 High dose | Experimental | - DA-5202 20mg Receives: Drug: DA-5202 20mg |
| DA-5202 Low dose | Experimental | - DA-5202 10mg Receives: Drug: DA-5202 10mg |
| Na Hyaluronate 20mg | Active comparator | Na Hyaluronate 20mg Receives: Drug: Na Hyaluronate 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of 100mm-VAS about weight bearing pain in study knee at week 3
Measured: week 3
Secondary outcomes (8)
Change from baseline of 100mm-VAS about Weight bearing pain in study knee at week 1,2,7,12
Measured: week 1,2,7,12
Change from baseline of 100mm-VAS about Resting pain in study knee at week 1,2,3,7,12
Measured: week 1,2,3,7,12
knee joint range of motion change (Observation by investigator)
Measured: 24 weeks
knee joint effusion change (Observation by investigator)
Measured: 24 weeks
overall assessment of subject and investigator (5-Likert scale)
Measured: week 1,2,3,7,12
Change from baseline of 100mm-VAS about Motion pain in study knee at week 1,2,3,7,12
Measured: week 1,2,3,7,12
Change from baseline of 100mm-VAS about Night pain in study knee at week 1,2,3,7,12
Measured: week 1,2,3,7,12
Change from baseline of WOMAC Index total score at Week 1,2,3,7,12
Measured: week 1,2,3,7,12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study start23 Dec 2014
- Primary completion29 Jun 2016
- Study completion14 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myung chul Lee, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554240
- Sponsor's protocol ID
- DA5202_KOA_II
- Status last verified
- Apr 2021
- First submitted
- 28 Apr 2015
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active-controlled, Dose-Response, Randomized, Double-blind, Therapeutic Exploratory Clinical Trial to Evaluate the Efficacy and Safety of Intra-articular DA-5202 in Patients With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT02554240
- Acronym / sponsor ID
- DA5202_KOA_II
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Dec 2014 (actual)
- Primary completion
- 29 Jun 2016 (actual)
- Study completion
- 14 Oct 2016 (actual)
- First posted
- 18 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase II clinical study is to evaluate the efficacy and safety of DA-5202 in patients with osteoarthritis of the knee.
Detailed description
Eligible subjects are randomly assigned to receive DA-5202 high dose(20mg) or DA-5202 low dose(10mg) or Na Hyaluronate once a week intra-articular injection for 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DA-5202 High dose | Experimental | Drug: DA-5202 20mg- DA-5202 20mg |
| DA-5202 Low dose | Experimental | Drug: DA-5202 10mg- DA-5202 10mg |
| Na Hyaluronate 20mg | Active comparator | Drug: Na Hyaluronate 20mgNa Hyaluronate 20mg |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- male and female patients between 20 and 80 y old
- primary knee osteoarthritis confirmed clinically and radiologically according to American College of Rheumatology criteria and have following 3 items
- 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
Key exclusion criteria (17 listed)
- BMI(Body Mass Index) > 32
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DA-5202 20mgAlso: DA-5202 high doseonce a week, intra-articular injection, for 3 weeks | Drug | DA-5202 High dose |
| DA-5202 10mgAlso: DA-5202 low doseonce a week, intra-articular injection, for 3 weeks | Drug | DA-5202 Low dose |
| Na Hyaluronate 20mgAlso: Hyruan Plus®once a week, intra-articular injection, for 3 weeks | Drug | Na Hyaluronate 20mg |
Primary outcome
Change from baseline of 100mm-VAS about weight bearing pain in study knee at week 3
Time frame: week 3
8 secondary outcomes
Change from baseline of 100mm-VAS about Weight bearing pain in study knee at week 1,2,7,12
Time frame: week 1,2,7,12
Change from baseline of 100mm-VAS about Resting pain in study knee at week 1,2,3,7,12
Time frame: week 1,2,3,7,12
knee joint range of motion change (Observation by investigator)
Time frame: 24 weeks
knee joint effusion change (Observation by investigator)
Time frame: 24 weeks
overall assessment of subject and investigator (5-Likert scale)
Time frame: week 1,2,3,7,12
Change from baseline of 100mm-VAS about Motion pain in study knee at week 1,2,3,7,12
Time frame: week 1,2,3,7,12
Change from baseline of 100mm-VAS about Night pain in study knee at week 1,2,3,7,12
Time frame: week 1,2,3,7,12
Change from baseline of WOMAC Index total score at Week 1,2,3,7,12
Time frame: week 1,2,3,7,12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myung chul Lee, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DA-5202 20mg, DA-5202 10mg and Na Hyaluronate 20mg in people with Osteoarthritis, Knee, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of 100mm-VAS about weight bearing pain in study knee at week 3 (time frame: week 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.