Clinical trial to evaluate the Efficacy and safety of DH004 in patients with mild to moderate knee osteoarthritis

A multicenter, randomized, double-blind phase ?/? clinical trial to evaluate the Efficacy and safety of DH004 versus Hyaluronic acid in patients with mild to moderate knee osteoarthritis

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0000074

Enrollment

267

Registered

2010-12-31

Start date

2010-06-17

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Intrraarticular injection, 1/wk, 5 consecutive weekly

DH004 2.5ml,4ml, or hyaluronic acid 2.5ml

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Visual analogue scale	—

Secondary

Measure	Time frame
generalized evaluation of patient;generalized evaluation of physician;Korean version WOMAC	—

Countries

Korea, Republic of

Contacts

Public ContactHee-sang Kim

KyungHee University Medical Center

Outcome results