Clinical trial NCT01183624: A Controlled Study of an Herbal Topical Patch in Treating Osteoarthritis (OA) of the Knee
Official title: A Multi-Center, Randomized, Double-Blind, Parallel, Placebo Control Study of a Traditional Chinese Medicine Topical Analgesic Patch in the Treatment of Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis
Pain
Herbal medicine
Topical administration
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2010-08-17
Enrollment: 626
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 efficacy and safety of the patch in relieving OA knee pain.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Pain Score
timeFrame: Day 7
Secondary outcomes:
measure: Subject Assessment
timeFrame: Day 3
measure: Subject Assessment
timeFrame: Day 7
measure: Subject Assessment
timeFrame: Day 14
measure: Investigator Assessment
timeFrame: Day 3
measure: Investigator Assessment
timeFrame: Day 7
measure: Investigator Assessment
timeFrame: Day 14
Other outcomes:
Locations:
city: Luoyang
country: China
facility: Luoyang Orthopedic & Traumatologic Hospital of Henan Province
state: Hubei
city: Wu Han
country: China
facility: Union Hospital affiliated to Tong Ji Medical College
state: Hubei
city: Changsha City
country: China
facility: Xiangya Hospital Central-South University
state: Hunan
city: Nanjing
country: China
facility: Jiang Su Province Hospital of TCM Hospital
state: Jiangsu
city: Suzhou
country: China
facility: Su Zhou Chinese Medicine Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Wu Xi Chinese Medical Hospital
state: Jiangsu
city: Xianyang
country: China
facility: Affiliated Hospital of Shan Xi TCM College
state: Shaanxi
city: Shanghai
country: China
facility: Shanghai Chinese Medical Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Rui Jin Hospital
state: Shanghai
city: Xi'an
country: China
facility: Shan Xi Provincial People's Hospital
state: Shanxi
city: Chengdu
country: China
facility: Affiliated Hospital of Chengdu University of TCM
state: Sichuan
city: TianJin
country: China
facility: 1st Affiliated Hospital of Tian Jin TCM College
state: Tianjin
Study officials:
affiliation: Johnson & Johnson China
name: Jackie (Yun) Mao
role: STUDY_DIRECTOR
References: