Clinical trial to evaluate the Efficacy and safety of DH004 in patients with mild to moderate knee osteoarthritis
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0000074
- Lead Sponsor
- Daihan Pharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 267
1) 20 yrs older male and female
2) osteoarthritis at knee
3) pain VAS> 30mm
4) ACR criteria and any of older than 50 yrs, morning stiffness lasting 30min, crepitus
5) general evaluation 3-5/5, agreement of informed consent
1) Coexisted hip, or other osteoarthritis
2) Psoriasis
3) Sacroiliitis
4) other arthritis than osteoarthritis
5) 2ndry arthritis; traumatic arthritis, ochronosis, hemochromatosis
6) infectious arthritis
7) generalized poor health atatus
8) dermatitis around injection site
9) severe hepatic dysfunction or hystory
10) hypersensitivity at avian protein
11) hypersensitivity at hyaluronic acid
12) severe pain disorder ; Sudek's atrophy Paget's disease
13) needed medical intervention
14) recent 3mos, steroid or radiocolloid injection Hx
15) needed intra- articular corticosteroid, NSAIDs, analgesic, or physiotherapy
16) analgesics in 2 days
17) any other clinicla trial participants
18) legal or psychological problem
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Visual analogue scale
- Secondary Outcome Measures
Name Time Method generalized evaluation of patient;generalized evaluation of physician;Korean version WOMAC