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

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Other: Herbal Patch; Other: Placebo Patch

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.

• Study Type: Interventional
• Enrollment (Actual): 626
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Hubei
    • Luoyang, Hubei, China
      • Luoyang Orthopedic & Traumatologic Hospital of Henan Province
    • Wu Han, Hubei, China
      • Union Hospital affiliated to Tong Ji Medical College
  • Hunan
    • Changsha City, Hunan, China, 410008
      • Xiangya Hospital Central-South University
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Jiang Su Province Hospital of TCM Hospital
    • Suzhou, Jiangsu, China, 215003
      • Su Zhou Chinese Medicine Hospital
    • Wuxi, Jiangsu, China
      • Wu Xi Chinese Medical Hospital
  • Shaanxi
    • Xianyang, Shaanxi, China
      • Affiliated Hospital of Shan Xi TCM College
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai Chinese Medical Hospital
    • Shanghai, Shanghai, China
      • Shanghai Rui Jin Hospital
  • Shanxi
    • Xi'an, Shanxi, China
      • Shan Xi Provincial People's Hospital
  • Sichuan
    • Chengdu, Sichuan, China
      • Affiliated Hospital of Chengdu University of TCM
  • Tianjin
    • TianJin, Tianjin, China
      • 1st Affiliated Hospital of Tian Jin TCM College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Patch; Herbal Patch	Other: Herbal Patch; 1 herbal patch applied for approximately 8 hours per day for 14 days; Other Names: Traditional Chinese Medicine Topical Analgesic Patch
Placebo Comparator: Control Patch; Placebo Patch	Other: Placebo Patch; Control patch with no herbal ingredients; Other Names: Not a marketed product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score	The WOMAC (Western Ontario and McMaster Universities Index of Osteoarthritis) Pain Subscale Score	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Assessment	Subject Global Assessment of Response to Treatment: WOMAC Physical Function Subscale and Subject Global Assessment of OA Condition	Day 3
Subject Assessment	Subject Global Assessment of Response to Treatment: WOMAC Physical Function Subscale and Subject Global Assessment of OA Condition	Day 7
Subject Assessment	Subject Global Assessment of Response to Treatment: WOMAC Physical Function Subscale and Subject Global Assessment of OA Condition	Day 14
Investigator Assessment	Investigator Global TCM Assessment of OA Condition: WOMAC Stiffness Subscale, Total WOMAC Index	Day 3
Investigator Assessment	Investigator Global TCM Assessment of OA Condition: WOMAC Stiffness Subscale, Total WOMAC Index	Day 7
Investigator Assessment	Investigator Global TCM Assessment of OA Condition: WOMAC Stiffness Subscale, Total WOMAC Index	Day 14

Collaborators and Investigators

• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
• Investigators: Study Director: Jackie (Yun) Mao, Johnson & Johnson China

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: August 13, 2010
• First Submitted That Met QC Criteria: August 13, 2010
• First Posted (Estimate): August 17, 2010

Study Record Updates

• Last Update Posted (Estimate): January 8, 2016
• Last Update Submitted That Met QC Criteria: January 6, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Osteoarthritis; Pain; Herbal medicine; Topical administration
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics
• Other Study ID Numbers: HCTPAI3001