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Study to Evaluate the Efficacy and Safety of Intra-articular DA-5202 in Patients With Osteoarthritis of the Knee

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DA-5202 20mg
DA-5202 10mg
Na Hyaluronate 20mg
Sponsored by
Dong-A ST Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

    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:

  • 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
  • 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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

DA-5202 High dose

DA-5202 Low dose

Na Hyaluronate 20mg

Arm Description

- DA-5202 20mg

- DA-5202 10mg

Na Hyaluronate 20mg

Outcomes

Primary Outcome Measures

Change from baseline of 100mm-VAS about weight bearing pain in study knee at week 3

Secondary Outcome Measures

Change from baseline of 100mm-VAS about Weight bearing pain in study knee at week 1,2,7,12
Change from baseline of 100mm-VAS about Resting pain in study knee at week 1,2,3,7,12
knee joint range of motion change (Observation by investigator)
knee joint effusion change (Observation by investigator)
overall assessment of subject and investigator (5-Likert scale)
Change from baseline of 100mm-VAS about Motion pain in study knee at 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
Change from baseline of WOMAC Index total score at Week 1,2,3,7,12

Full Information

First Posted
April 28, 2015
Last Updated
April 13, 2021
Sponsor
Dong-A ST Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02554240
Brief Title
Study to Evaluate the Efficacy and Safety of Intra-articular DA-5202 in Patients With Osteoarthritis of the Knee
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 23, 2014 (Actual)
Primary Completion Date
June 29, 2016 (Actual)
Study Completion Date
October 14, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A ST Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DA-5202 High dose
Arm Type
Experimental
Arm Description
- DA-5202 20mg
Arm Title
DA-5202 Low dose
Arm Type
Experimental
Arm Description
- DA-5202 10mg
Arm Title
Na Hyaluronate 20mg
Arm Type
Active Comparator
Arm Description
Na Hyaluronate 20mg
Intervention Type
Drug
Intervention Name(s)
DA-5202 20mg
Other Intervention Name(s)
DA-5202 high dose
Intervention Description
once a week, intra-articular injection, for 3 weeks
Intervention Type
Drug
Intervention Name(s)
DA-5202 10mg
Other Intervention Name(s)
DA-5202 low dose
Intervention Description
once a week, intra-articular injection, for 3 weeks
Intervention Type
Drug
Intervention Name(s)
Na Hyaluronate 20mg
Other Intervention Name(s)
Hyruan Plus®
Intervention Description
once a week, intra-articular injection, for 3 weeks
Primary Outcome Measure Information:
Title
Change from baseline of 100mm-VAS about weight bearing pain in study knee at week 3
Time Frame
week 3
Secondary Outcome Measure Information:
Title
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
Title
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
Title
knee joint range of motion change (Observation by investigator)
Time Frame
24 weeks
Title
knee joint effusion change (Observation by investigator)
Time Frame
24 weeks
Title
overall assessment of subject and investigator (5-Likert scale)
Time Frame
week 1,2,3,7,12
Title
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
Title
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
Title
Change from baseline of WOMAC Index total score at Week 1,2,3,7,12
Time Frame
week 1,2,3,7,12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myung chul Lee, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Study to Evaluate the Efficacy and Safety of Intra-articular DA-5202 in Patients With Osteoarthritis of the Knee

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