Back to resultsA Controlled Study of an Herbal Topical Patch in Treating Osteoarthritis (OA) of the Knee
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Herbal Patch
Placebo Patch
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, Pain, Herbal medicine, Topical administration
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.
Sites / Locations
- Luoyang Orthopedic & Traumatologic Hospital of Henan Province
- Union Hospital affiliated to Tong Ji Medical College
- Xiangya Hospital Central-South University
- Jiang Su Province Hospital of TCM Hospital
- Su Zhou Chinese Medicine Hospital
- Wu Xi Chinese Medical Hospital
- Affiliated Hospital of Shan Xi TCM College
- Shanghai Chinese Medical Hospital
- Shanghai Rui Jin Hospital
- Shan Xi Provincial People's Hospital
- Affiliated Hospital of Chengdu University of TCM
- 1st Affiliated Hospital of Tian Jin TCM College
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental Patch
Control Patch
Arm Description
Herbal Patch
Placebo Patch
Outcomes
Primary Outcome Measures
Pain Score
The WOMAC (Western Ontario and McMaster Universities Index of Osteoarthritis) Pain Subscale Score
Secondary Outcome Measures
Subject Assessment
Subject Global Assessment of Response to Treatment: WOMAC Physical Function Subscale and Subject Global Assessment of OA Condition
Subject Assessment
Subject Global Assessment of Response to Treatment: WOMAC Physical Function Subscale and Subject Global Assessment of OA Condition
Subject Assessment
Subject Global Assessment of Response to Treatment: WOMAC Physical Function Subscale and Subject Global Assessment of OA Condition
Investigator Assessment
Investigator Global TCM Assessment of OA Condition: WOMAC Stiffness Subscale, Total WOMAC Index
Investigator Assessment
Investigator Global TCM Assessment of OA Condition: WOMAC Stiffness Subscale, Total WOMAC Index
Investigator Assessment
Investigator Global TCM Assessment of OA Condition: WOMAC Stiffness Subscale, Total WOMAC Index
Full Information
NCT ID
NCT01183624
First Posted
August 13, 2010
Last Updated
January 6, 2016
Sponsor
Johnson & Johnson Consumer and Personal Products Worldwide
1. Study Identification
Unique Protocol Identification Number
NCT01183624
Brief Title
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
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Consumer and Personal Products Worldwide
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Osteoarthritis, Pain, Herbal medicine, Topical administration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
626 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Patch
Arm Type
Experimental
Arm Description
Herbal Patch
Arm Title
Control Patch
Arm Type
Placebo Comparator
Arm Description
Placebo Patch
Intervention Type
Other
Intervention Name(s)
Herbal Patch
Other Intervention Name(s)
Traditional Chinese Medicine Topical Analgesic Patch
Intervention Description
1 herbal patch applied for approximately 8 hours per day for 14 days
Intervention Type
Other
Intervention Name(s)
Placebo Patch
Other Intervention Name(s)
Not a marketed product
Intervention Description
Control patch with no herbal ingredients
Primary Outcome Measure Information:
Title
Pain Score
Description
The WOMAC (Western Ontario and McMaster Universities Index of Osteoarthritis) Pain Subscale Score
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Subject Assessment
Description
Subject Global Assessment of Response to Treatment: WOMAC Physical Function Subscale and Subject Global Assessment of OA Condition
Time Frame
Day 3
Title
Subject Assessment
Description
Subject Global Assessment of Response to Treatment: WOMAC Physical Function Subscale and Subject Global Assessment of OA Condition
Time Frame
Day 7
Title
Subject Assessment
Description
Subject Global Assessment of Response to Treatment: WOMAC Physical Function Subscale and Subject Global Assessment of OA Condition
Time Frame
Day 14
Title
Investigator Assessment
Description
Investigator Global TCM Assessment of OA Condition: WOMAC Stiffness Subscale, Total WOMAC Index
Time Frame
Day 3
Title
Investigator Assessment
Description
Investigator Global TCM Assessment of OA Condition: WOMAC Stiffness Subscale, Total WOMAC Index
Time Frame
Day 7
Title
Investigator Assessment
Description
Investigator Global TCM Assessment of OA Condition: WOMAC Stiffness Subscale, Total WOMAC Index
Time Frame
Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jackie (Yun) Mao
Organizational Affiliation
Johnson & Johnson China
Official's Role
Study Director
Facility Information:
Facility Name
Luoyang Orthopedic & Traumatologic Hospital of Henan Province
City
Luoyang
State/Province
Hubei
Country
China
Facility Name
Union Hospital affiliated to Tong Ji Medical College
City
Wu Han
State/Province
Hubei
Country
China
Facility Name
Xiangya Hospital Central-South University
City
Changsha City
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Jiang Su Province Hospital of TCM Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Su Zhou Chinese Medicine Hospital
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215003
Country
China
Facility Name
Wu Xi Chinese Medical Hospital
City
Wuxi
State/Province
Jiangsu
Country
China
Facility Name
Affiliated Hospital of Shan Xi TCM College
City
Xianyang
State/Province
Shaanxi
Country
China
Facility Name
Shanghai Chinese Medical Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanghai Rui Jin Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shan Xi Provincial People's Hospital
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
Affiliated Hospital of Chengdu University of TCM
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
1st Affiliated Hospital of Tian Jin TCM College
City
TianJin
State/Province
Tianjin
Country
China
12. IPD Sharing Statement
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A Controlled Study of an Herbal Topical Patch in Treating Osteoarthritis (OA) of the Knee
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