Osteoarthritis, KneePhase 4NCT01183624
A Controlled Study of an Herbal Topical Patch in Treating Osteoarthritis (OA) of the Knee
A Phase 4 study testing Herbal Patch in people with Osteoarthritis, Knee, run by Johnson & Johnson Consumer and Personal Products Worldwide at 12 sites in China.
Trial summary
An evaluation of the safety and efficacy of an herbal patch in treating osteoarthritis pain of the right or left knee. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Herbal Patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 626 participants
- Where
- 12 sitesChina
- Study dates
- Jul 2010to Apr 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Xiangya Hospital Central-South University
Changsha, Hunan, 410008
Affiliated Hospital of Chengdu University of TCM
Chengdu, Sichuan
Luoyang Orthopedic & Traumatologic Hospital of Henan Province
Luoyang, Hubei
Jiang Su Province Hospital of TCM Hospital
Nanjing, Jiangsu
Shanghai Chinese Medical Hospital
Shanghai, Shanghai Municipality
Shanghai Rui Jin Hospital
Shanghai, Shanghai Municipality
Su Zhou Chinese Medicine Hospital
Suzhou, Jiangsu, 215003
1st Affiliated Hospital of Tian Jin TCM College
Tianjin, Tianjin Municipality
Union Hospital affiliated to Tong Ji Medical College
Wuhan, Hubei
Wu Xi Chinese Medical Hospital
Wuxi, Jiangsu
Shan Xi Provincial People's Hospital
Xi’an, Shanxi
Affiliated Hospital of Shan Xi TCM College
Xianyang, Shaanxi
About this study
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
An evaluation of the safety and efficacy of an herbal patch in treating osteoarthritis pain of the right or left knee.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Herbal Patch, Placebo Patch
- Keywords
- Osteoarthritis, Pain, Herbal medicine, Topical administration
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbal PatchOther
Also called Traditional Chinese Medicine Topical Analgesic Patch
1 herbal patch applied for approximately 8 hours per day for 14 days
Placebo PatchOther
Also called Not a marketed product
Control patch with no herbal ingredients
| Study group | Role | What they receive |
|---|---|---|
| Experimental Patch | Experimental | Herbal Patch Receives: Other: Herbal Patch |
| Control Patch | Placebo comparator | Placebo Patch Receives: Other: Placebo Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
The WOMAC (Western Ontario and McMaster Universities Index of Osteoarthritis) Pain Subscale Score
Measured: Day 7
Secondary outcomes (6)
Subject Assessment
Subject Global Assessment of Response to Treatment: WOMAC Physical Function Subscale and Subject Global Assessment of OA Condition
Measured: Day 3
Subject Assessment
Subject Global Assessment of Response to Treatment: WOMAC Physical Function Subscale and Subject Global Assessment of OA Condition
Measured: Day 7
Subject Assessment
Subject Global Assessment of Response to Treatment: WOMAC Physical Function Subscale and Subject Global Assessment of OA Condition
Measured: Day 14
Investigator Assessment
Investigator Global TCM Assessment of OA Condition: WOMAC Stiffness Subscale, Total WOMAC Index
Measured: Day 3
Investigator Assessment
Investigator Global TCM Assessment of OA Condition: WOMAC Stiffness Subscale, Total WOMAC Index
Measured: Day 7
Investigator Assessment
Investigator Global TCM Assessment of OA Condition: WOMAC Stiffness Subscale, Total WOMAC Index
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 626 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jackie (Yun) Mao, Study director, Johnson & Johnson China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183624
- Sponsor's protocol ID
- HCTPAI3001
- Status last verified
- Jan 2016
- First submitted
- 13 Aug 2010
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01183624
- Acronym / sponsor ID
- HCTPAI3001
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Pain, Herbal medicine, Topical administration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 626 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 17 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Patch | Experimental | Other: Herbal PatchHerbal Patch |
| Control Patch | Placebo comparator | Other: Placebo PatchPlacebo Patch |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herbal PatchAlso: Traditional Chinese Medicine Topical Analgesic Patch1 herbal patch applied for approximately 8 hours per day for 14 days | Other | Experimental Patch |
| Placebo PatchAlso: Not a marketed productControl patch with no herbal ingredients | Other | Control Patch |
Primary outcome
Pain Score
Time frame: Day 7
The WOMAC (Western Ontario and McMaster Universities Index of Osteoarthritis) Pain Subscale Score
6 secondary outcomes
Subject Assessment
Time frame: Day 3
Subject Assessment
Time frame: Day 7
Subject Assessment
Time frame: Day 14
Investigator Assessment
Time frame: Day 3
Investigator Assessment
Time frame: Day 7
Investigator Assessment
Time frame: Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jackie (Yun) Mao study director
Johnson & Johnson China
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Herbal Patch in people with Osteoarthritis, Knee, run by Johnson & Johnson Consumer and Personal Products Worldwide at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.