Status:
COMPLETED
A Controlled Study of an Herbal Topical Patch in Treating Osteoarthritis (OA) of the Knee
Lead Sponsor:
Johnson & Johnson Consumer and Personal Products Worldwide
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
40-70 years
Phase:
PHASE4
Brief Summary
An evaluation of the safety and efficacy of an herbal patch in treating osteoarthritis pain of the right or left knee.
Detailed Description
This is a multi-center, randomized, double-blind, parallel-group, placebo-controlled study of herbal patch in subjects with OA knee pain. The overall objective of this study is to evaluate the efficac...
Eligibility Criteria
Inclusion
- Male or female between 40 and 70 years of age
- Medically cleared to participate by a site affiliated physician following a physical
- History of, or current diagnosis of, OA of the knee
- Evidence of idiopathic OA of at least one knee
- Subject Assessment of OA pain in target knee 40 - 75 mm (on the 100 mm VAS inclusive) in the index knee, on the WOMAC Pain composite subscale at Visit 1
- Subject Assessment of OA pain in non-index knee (if applicable) is ≤ 20mm
- Subject Global Assessment of OA Condition (5 pt categorical scale, 1 = very good to 5 = very poor) of grade 3-5 (i.e. fair, poor or very poor)
- Evidence of idiopathic OA of at least one knee as defined by the American College of Rheumatology Classification (ACR) of OA of the Knee
Exclusion
- Grade 1 or Grade 4 severity of the index knee based on the Kellgren and Lawrence radiographic criteria
- Pain greater than 20 mm on the VAS in the non-index knee (either at rest or with movement)
- Prior injection or arthroscopy of study knee within 3 months
- Crystalline-induced synovitis (e.g. gout, pseudo gout, nonsteroid arthritis, hydroxyapatite deposit), acute inflammatory arthritis, rheumatoid arthritis, psoriatic arthritis, septic arthritis, fibromyalgia, systemic lupus, erythematosus collagen vascular disease or other types of inflammatory arthritis in the index knee
- Pain in either knee is of neurological origin
- An injury or surgery to the same body region within the prior 6 months or a lifetime history of 3 or more injuries/surgeries to the injured body region
- Signs of clinically important active inflammation of the study knee joint including redness, warmth, and/or a large, bulging effusion with the loss of normal contour at the screening and/or baseline visits
- Other criteria that - in the opinion of the investigator - may jeopardize the safety of the subject or the study results.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
626 Patients enrolled
Trial Details
Trial ID
NCT01183624
Start Date
July 1 2010
End Date
April 1 2011
Last Update
January 8 2016
Active Locations (12)
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1
Luoyang Orthopedic & Traumatologic Hospital of Henan Province
Luoyang, Hubei, China
2
Union Hospital affiliated to Tong Ji Medical College
Wuhan, Hubei, China
3
Xiangya Hospital Central-South University
Changsha, Hunan, China, 410008
4
Jiang Su Province Hospital of TCM Hospital
Nanjing, Jiangsu, China