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

Phase 2

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Drug: DA-5202 10mg; Drug: DA-5202 20mg; Drug: Na Hyaluronate 20mg

• Registration Number: NCT02554240
• Lead Sponsor: Dong-A ST Co., Ltd.

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.

Study Timeline

• Study Start: 2014-12-23
• Study First Submitted: 2015-04-28
• Study First Submitted QC: 2015-09-17
• Study First Posted: 2015-09-18
• Primary Completion: 2016-06-29
• Study Completion: 2016-10-14
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-13
• Last Update Posted: 2021-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DA-5202 Low dose	DA-5202 10mg	- DA-5202 10mg
DA-5202 High dose	DA-5202 20mg	- DA-5202 20mg
Na Hyaluronate 20mg	Na Hyaluronate 20mg	Na Hyaluronate 20mg

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change from baseline of 100mm-VAS about Weight bearing pain in study knee at week 1,2,7,12	week 1,2,7,12
knee joint effusion change (Observation by investigator)	24 weeks
knee joint range of motion change (Observation by investigator)	24 weeks
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
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of