A Controlled Study of an Herbal Topical Patch in Treating Osteoarthritis (OA) of the Knee

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01183624
• Other study ID #: HCTPAI3001
• Status: Completed
• Phase: Phase 4
• First received: August 13, 2010
• Last updated: January 6, 2016
• Start date: July 2010
• Est. completion date: April 2011

Study information

• Verified date: January 2016
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

An evaluation of the safety and efficacy of an herbal patch in treating osteoarthritis pain of the right or left knee.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 626
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Herbal Patch
1 herbal patch applied for approximately 8 hours per day for 14 days
• Placebo Patch
Control patch with no herbal ingredients

Locations

Country	Name	City	State
China	Xiangya Hospital Central-South University	Changsha City	Hunan
China	Affiliated Hospital of Chengdu University of TCM	Chengdu	Sichuan
China	Luoyang Orthopedic & Traumatologic Hospital of Henan Province	Luoyang	Hubei
China	Jiang Su Province Hospital of TCM Hospital	Nanjing	Jiangsu
China	Shanghai Chinese Medical Hospital	Shanghai	Shanghai
China	Shanghai Rui Jin Hospital	Shanghai	Shanghai
China	Su Zhou Chinese Medicine Hospital	Suzhou	Jiangsu
China	1st Affiliated Hospital of Tian Jin TCM College	TianJin	Tianjin
China	Union Hospital affiliated to Tong Ji Medical College	Wu Han	Hubei
China	Wu Xi Chinese Medical Hospital	Wuxi	Jiangsu
China	Shan Xi Provincial People's Hospital	Xi'an	Shanxi
China	Affiliated Hospital of Shan Xi TCM College	Xianyang	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Consumer and Personal Products Worldwide

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score	The WOMAC (Western Ontario and McMaster Universities Index of Osteoarthritis) Pain Subscale Score	Day 7	No
Secondary	Subject Assessment	Subject Global Assessment of Response to Treatment: WOMAC Physical Function Subscale and Subject Global Assessment of OA Condition	Day 3	No
Secondary	Subject Assessment	Subject Global Assessment of Response to Treatment: WOMAC Physical Function Subscale and Subject Global Assessment of OA Condition	Day 7	No
Secondary	Subject Assessment	Subject Global Assessment of Response to Treatment: WOMAC Physical Function Subscale and Subject Global Assessment of OA Condition	Day 14	No
Secondary	Investigator Assessment	Investigator Global TCM Assessment of OA Condition: WOMAC Stiffness Subscale, Total WOMAC Index	Day 3	No
Secondary	Investigator Assessment	Investigator Global TCM Assessment of OA Condition: WOMAC Stiffness Subscale, Total WOMAC Index	Day 7	No
Secondary	Investigator Assessment	Investigator Global TCM Assessment of OA Condition: WOMAC Stiffness Subscale, Total WOMAC Index	Day 14	No