Clinical trial NCT02554240: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-09-18
Enrollment: 115
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

  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

Primary outcomes:
measure: Change from baseline of 100mm-VAS about weight bearing pain in study knee at week 3
timeFrame: week 3
Secondary outcomes:
measure: Change from baseline of 100mm-VAS about Weight bearing pain in study knee at week 1,2,7,12
timeFrame: week 1,2,7,12
measure: Change from baseline of 100mm-VAS about Resting pain in study knee at week 1,2,3,7,12
timeFrame: week 1,2,3,7,12
measure: knee joint range of motion change (Observation by investigator)
timeFrame: 24 weeks
measure: knee joint effusion change (Observation by investigator)
timeFrame: 24 weeks
measure: overall assessment of subject and investigator (5-Likert scale)
timeFrame: week 1,2,3,7,12
measure: Change from baseline of 100mm-VAS about Motion pain in study knee at week 1,2,3,7,12
timeFrame: week 1,2,3,7,12
measure: Change from baseline of 100mm-VAS about Night pain in study knee at week 1,2,3,7,12
timeFrame: week 1,2,3,7,12
measure: Change from baseline of WOMAC Index total score at Week 1,2,3,7,12
timeFrame: week 1,2,3,7,12
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Myung chul Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: