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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:
NCT01183624
First received: August 13, 2010
Last updated: October 4, 2011
Last verified: October 2011
  Purpose

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


Condition Intervention Phase
Osteoarthritis, Knee
Other: Herbal Patch
Other: Placebo Patch
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • Pain Score [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    The WOMAC (Western Ontario and McMaster Universities Index of Osteoarthritis) Pain Subscale Score


Secondary Outcome Measures:
  • Subject Assessment [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    Subject Global Assessment of Response to Treatment: WOMAC Physical Function Subscale and Subject Global Assessment of OA Condition

  • Subject Assessment [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    Subject Global Assessment of Response to Treatment: WOMAC Physical Function Subscale and Subject Global Assessment of OA Condition

  • Subject Assessment [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    Subject Global Assessment of Response to Treatment: WOMAC Physical Function Subscale and Subject Global Assessment of OA Condition

  • Investigator Assessment [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    Investigator Global TCM Assessment of OA Condition: WOMAC Stiffness Subscale, Total WOMAC Index

  • Investigator Assessment [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    Investigator Global TCM Assessment of OA Condition: WOMAC Stiffness Subscale, Total WOMAC Index

  • Investigator Assessment [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    Investigator Global TCM Assessment of OA Condition: WOMAC Stiffness Subscale, Total WOMAC Index


Enrollment: 626
Study Start Date: July 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Patch
Herbal Patch
Other: Herbal Patch
1 herbal patch applied for approximately 8 hours per day for 14 days
Other Name: Traditional Chinese Medicine Topical Analgesic Patch
Placebo Comparator: Control Patch
Placebo Patch
Other: Placebo Patch
Control patch with no herbal ingredients
Other Name: Not a marketed product

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

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01183624

Locations
China, Gan Su Province
Affiliated Hospital of Shan Xi TCM College
Xi An, Gan Su Province, China
China, He Nan Province
Luoyang Orthopedic & Traumatologic Hospital of Henan Province
Luoyang, He Nan Province, China
Jiang Su Province Hospital of TCM Hospital
Zhengzhou, He Nan Province, China
China, Hu Bei Province
Union Hospital affiliated to Tong Ji Medical College
Wu Han, Hu Bei Province, China
China, Hunan
Xiangya Hospital Central-South University
Changsha City, Hunan, China, 410008
China, Jiangsu
Su Zhou Chinese Medicine Hospital
Suzhou, Jiangsu, China, 215003
Wu Xi Chinese Medical Hospital
Wuxi, Jiangsu, China
China, Shanghai
Shanghai Rui Jin Hospital
Shanghai, Shanghai, China
Shanghai Chinese Medical Hospital
Shanghai, Shanghai, China
China, Shanxi
Shan Xi Provincial People's Hospital
Xi'an, Shanxi, China
China, Sichuan
Affiliated Hospital of Chengdu University of TCM
Chengdu, Sichuan, China
China, Tian Jing
1st Affiliated Hospital of Tian Jin TCM College
TianJing, Tian Jing, China
Sponsors and Collaborators
Johnson & Johnson Consumer and Personal Products Worldwide
Investigators
Study Director: Jackie (Yun) Mao Johnson & Johnson China
  More Information

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT01183624     History of Changes
Other Study ID Numbers: HCTPAI3001
Study First Received: August 13, 2010
Last Updated: October 4, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
Osteoarthritis
Pain
Herbal medicine
Topical administration

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014