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

January 6, 2016 updated by: Johnson & Johnson Consumer and Personal Products Worldwide

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
626

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

36 years to 66 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Score
Time Frame: Day 7
The WOMAC (Western Ontario and McMaster Universities Index of Osteoarthritis) Pain Subscale Score
Day 7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subject Assessment
Time Frame: Day 3
Subject Global Assessment of Response to Treatment: WOMAC Physical Function Subscale and Subject Global Assessment of OA Condition
Day 3
Subject Assessment
Time Frame: Day 7
Subject Global Assessment of Response to Treatment: WOMAC Physical Function Subscale and Subject Global Assessment of OA Condition
Day 7
Subject Assessment
Time Frame: Day 14
Subject Global Assessment of Response to Treatment: WOMAC Physical Function Subscale and Subject Global Assessment of OA Condition
Day 14
Investigator Assessment
Time Frame: Day 3
Investigator Global TCM Assessment of OA Condition: WOMAC Stiffness Subscale, Total WOMAC Index
Day 3
Investigator Assessment
Time Frame: Day 7
Investigator Global TCM Assessment of OA Condition: WOMAC Stiffness Subscale, Total WOMAC Index
Day 7
Investigator Assessment
Time Frame: Day 14
Investigator Global TCM Assessment of OA Condition: WOMAC Stiffness Subscale, Total WOMAC Index
Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johnson & Johnson Consumer and Personal Products Worldwide

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jackie (Yun) Mao, Johnson & Johnson China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HCTPAI3001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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