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

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02554240
• Other study ID #: DA5202_KOA_II
• Status: Completed
• Phase: Phase 2
• Start date: December 23, 2014
• Est. completion date: October 14, 2016

Study information

• Verified date: April 2021
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This Phase II clinical study is to evaluate the efficacy and safety of DA-5202 in patients with osteoarthritis of the knee.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: October 14, 2016
• Est. primary completion date: June 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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 ? to ? 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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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