A Controlled Study of an Herbal Topical Patch in Treating Osteoarthritis (OA) of the Knee
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
1 other identifier
interventional
626
1 country
12
Brief Summary
An evaluation of the safety and efficacy of an herbal patch in treating osteoarthritis pain of the right or left knee.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2010
Shorter than P25 for phase_4
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 13, 2010
CompletedFirst Posted
Study publicly available on registry
August 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedJanuary 8, 2016
January 1, 2016
9 months
August 13, 2010
January 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain Score
The WOMAC (Western Ontario and McMaster Universities Index of Osteoarthritis) Pain Subscale Score
Day 7
Secondary Outcomes (6)
Subject Assessment
Day 3
Subject Assessment
Day 7
Subject Assessment
Day 14
Investigator Assessment
Day 3
Investigator Assessment
Day 7
- +1 more secondary outcomes
Study Arms (2)
Experimental Patch
EXPERIMENTALHerbal Patch
Control Patch
PLACEBO COMPARATORPlacebo Patch
Interventions
1 herbal patch applied for approximately 8 hours per day for 14 days
Control patch with no herbal ingredients
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Luoyang Orthopedic & Traumatologic Hospital of Henan Province
Luoyang, Hubei, China
Union Hospital affiliated to Tong Ji Medical College
Wuhan, Hubei, China
Xiangya Hospital Central-South University
Changsha, Hunan, 410008, China
Jiang Su Province Hospital of TCM Hospital
Nanjing, Jiangsu, China
Su Zhou Chinese Medicine Hospital
Suzhou, Jiangsu, 215003, China
Wu Xi Chinese Medical Hospital
Wuxi, Jiangsu, China
Affiliated Hospital of Shan Xi TCM College
Xianyang, Shaanxi, China
Shanghai Chinese Medical Hospital
Shanghai, Shanghai Municipality, China
Shanghai Rui Jin Hospital
Shanghai, Shanghai Municipality, China
Shan Xi Provincial People's Hospital
Xi’an, Shanxi, China
Affiliated Hospital of Chengdu University of TCM
Chengdu, Sichuan, China
1st Affiliated Hospital of Tian Jin TCM College
Tianjin, Tianjin Municipality, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jackie (Yun) Mao
Johnson & Johnson China
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2010
First Posted
August 17, 2010
Study Start
July 1, 2010
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
January 8, 2016
Record last verified: 2016-01