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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Drug: DA-5202 20mg; Drug: DA-5202 10mg; Drug: Na Hyaluronate 20mg

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 Type: Interventional
• Enrollment (Actual): 115
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DA-5202 High dose; - DA-5202 20mg	Drug: DA-5202 20mg; once a week, intra-articular injection, for 3 weeks; Other Names: DA-5202 high dose
EXPERIMENTAL: DA-5202 Low dose; - DA-5202 10mg	Drug: DA-5202 10mg; once a week, intra-articular injection, for 3 weeks; Other Names: DA-5202 low dose
ACTIVE_COMPARATOR: Na Hyaluronate 20mg	Drug: Na Hyaluronate 20mg; once a week, intra-articular injection, for 3 weeks; Other Names: Hyruan Plus®

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline of 100mm-VAS about Weight bearing pain in study knee at week 1,2,7,12	week 1,2,7,12
Change from baseline of 100mm-VAS about Resting pain in study knee at week 1,2,3,7,12	week 1,2,3,7,12
knee joint range of motion change (Observation by investigator)	24 weeks
knee joint effusion change (Observation by investigator)	24 weeks
overall assessment of subject and investigator (5-Likert scale)	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	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	week 1,2,3,7,12
Change from baseline of WOMAC Index total score at Week 1,2,3,7,12	week 1,2,3,7,12

Collaborators and Investigators

• Sponsor: Dong-A ST Co., Ltd.
• Investigators: Principal Investigator: Myung chul Lee, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 23, 2014
• Primary Completion (ACTUAL): June 29, 2016
• Study Completion (ACTUAL): October 14, 2016

Study Registration Dates

• First Submitted: April 28, 2015
• First Submitted That Met QC Criteria: September 17, 2015
• First Posted (ESTIMATE): September 18, 2015

Study Record Updates

• Last Update Posted (ACTUAL): April 14, 2021
• Last Update Submitted That Met QC Criteria: April 13, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: DA5202_KOA_II