Osteoarthritis, Knee JointPhase 3OAkneeNCT00471055
Efficacy Study on Symptomatic Control of Patient With Knee Osteoarthritis Between 0.0125% of Capsaicin to Placebo
A Phase 3 study testing 0.0125% Capsaicin gel "CAPSIKA gel" in people with Osteoarthritis, Knee Joint and Capsicum, run by Khon Kaen University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine whether capsaicin gel is effective in treating mild to moderate degrees of osteoarthritis of the knee in the elderly patient compared with placebo gel. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee Joint, Capsicum
- What is being tested?
- 0.0125% Capsaicin gel "CAPSIKA gel"
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2007to Dec 2007
- Phase
- Phase 3
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects eligible for enrollment in the study must meet all of the following criteria:
- Subjects who are capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Ambulatory nom pregnant females and males 40-<80 years of age.
- Subjects who withdraw pain medication or nutritional supplements for symptom relief for knee OA for a total of at least 15 days before screening visit 0.
- Pain at or below 80 mm on a 100 mm VAS in the index knee.
- A documented diagnosis of OA of the knee, or meeting American College of Rheumatology (ACR) clinical criteria for classification of idiopathic (primary) OA for at least 6 months prior to screening. If OA is presented in both knees the investigator will identify which knee will be X-rayed for study entry, with preference for the knee with more severe pain (<80mm VAS).
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- Has documented radiographic evidence of OA of the knee from the screening Visit radiograph of grade 2 or 3 according to Kellgren and Lawrence Radiographic Grading.
- Subjects with baseline minimum joint space width in the medial compartment of the index knee of > 1.5 mm at Baseline, measured from radiographs using the MTP view.
- Subjects with baseline minimum joint space width in the lateral compartment of the index knee of > 2.5 mm at Baseline, measured from radiographs using the MTP view.
- Subject is able to understand and complete pain/function, global arthritis evaluation, and health outcome assessment.
Who cannot join
- Subjects with any of the following criteria must not be enrolled in the study:
- Subjects with history of hypersensitivity to capsaicin.
- Subjects with skin lesion at the index knee.
- A history of lower extremity surgery within 6 months prior to screening V0.
- Significant prior injury to the index knee within 12 months prior to screening V0.
- Disease of the spine or other lower extremity joints of sufficient degree to affect the index knee.
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- Treatment with other drugs potentially affecting bone or cartilage metabolism as described below:
- chronic systematic corticosteroids
- hyaluronan injection into the index knee with in the previous 6 months.
- Diacerin treatment within the last 12 months.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Weerachai Kosuwon
Khon Kaen University, Changwat Khon Kaen, 40002
About this study
The purpose of this study is to determine whether capsaicin gel is effective in treating mild to moderate degrees of osteoarthritis of the knee in the elderly patient compared with placebo gel.
Read the detailed description
Osteoarthritis (OA) is the most common form of arthritis in the population. It is characterized pathologically by both focal loss of articular cartilage and marginal and central new bone formation. OA of knee, the principal large joint to be affected, results in disabling knee symptoms in an estimated 10% of people older than 55 years, a quarter of whom are severely disabled. The risk of disability attributable to knee OA alone is as great as that due to cardiac disease and greater than that due to any other medical disorder in the elderly. A recent World Health Organization report on the global burden of disease indicates that knee OA is likely to become the fourth most important global cause of disability in women and the eighth most important in men. Knee OA is associated with symptoms of pain and functional disability. Physical disability arising from pain and loss of functional capacity reduces quality of life and increases the risk of further morbidity and mortality. Current treatments aim at alleviating these symptoms of mild to moderate OA by several different methods: non-pharmacological treatment (for example education, exercise, lifestyle changes) or pharmacological treatments(for example paracetamol, NSAIDs and Capsaicin gel topical treatments). Current evidence to support the various treatments in current use, however, is very variable. Capsaicin, the active principle of hot chili pepper, is thought to selectively stimulate unmyelinated C fibre afferent neurons and cause the release of substance P. Prolonged application of capsaicin reversibly depletes stores of substance P, and possibly other neurotransmitters, from sensory nerve endings. This reduces or abolishes the transmission of painful stimuli from the peripheral nerve fibres to the higher centres.There were many study on Capsaicin gel to confirm the effectiveness of capsaicin gel in many dosages. However, there has been no efficacy study on the capsaicin 0.0125% of the Thai produce "Capsika gel " before, therefore, this study is proposed.
- Conditions
- Osteoarthritis, Knee Joint, Capsicum
- Being tested
- 0.0125% Capsaicin gel "CAPSIKA gel", Placebo
- Keywords
- osteoarthritis, knee, capsaicin gel, capsicum
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.0125% Capsaicin gel "CAPSIKA gel"Drug
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Capsaicin and placebo controlled,Cross-over design study Receives: Drug: 0.0125% Capsaicin gel "CAPSIKA gel" |
| B | Placebo comparator | Capsaicin and placebo controlled,Cross-over design study Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS and WOMAC
Measured: 8 months
VAS and WOMAC
Measured: 8-month study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2007 (estimated)
- Study startJun 2007
- Primary completionOct 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, Knee JointStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Collaborators
- Bangkok Laboratories and Cosmetics
- Investigators
- weerachai Kosuwon, M.D, Principal investigator, Department of Orthopedics, Faculty of Medicine, Khon kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00471055
- Sponsor's protocol ID
- Khonkaen-ortho 1
- Acronym
- OAknee
- Status last verified
- Apr 2008
- First submitted
- 8 May 2007
- Last updated
- 9 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study on Symptomatic Control of Patient With Knee Osteoarthritis Between 0.0125% of Capsaicin to Placebo
- ClinicalTrials.gov ID
- NCT00471055
- Acronym / sponsor ID
- OAknee / Khonkaen-ortho 1
- Conditions
- Osteoarthritis, Knee Joint, Capsicum
- Keywords
- osteoarthritis, knee, capsaicin gel, capsicum
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Collaborators
- Bangkok Laboratories and Cosmetics
- Study start
- Jun 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 9 May 2007 (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.
The purpose of this study is to determine whether capsaicin gel is effective in treating mild to moderate degrees of osteoarthritis of the knee in the elderly patient compared with placebo gel.
Detailed description
Osteoarthritis (OA) is the most common form of arthritis in the population. It is characterized pathologically by both focal loss of articular cartilage and marginal and central new bone formation. OA of knee, the principal large joint to be affected, results in disabling knee symptoms in an estimated 10% of people older than 55 years, a quarter of whom are severely disabled. The risk of disability attributable to knee OA alone is as great as that due to cardiac disease and greater than that due to any other medical disorder in the elderly. A recent World Health Organization report on the global burden of disease indicates that knee OA is likely to become the fourth most important global cause of disability in women and the eighth most important in men. Knee OA is associated with symptoms of pain and functional disability. Physical disability arising from pain and loss of functional capacity reduces quality of life and increases the risk of further morbidity and mortality. Current treatments aim at alleviating these symptoms of mild to moderate OA by several different methods: non-pharmacological treatment (for example education, exercise, lifestyle changes) or pharmacological treatments(for example paracetamol, NSAIDs and Capsaicin gel topical treatments). Current evidence to support the various treatments in current use, however, is very variable. Capsaicin, the active principle of hot chili pepper, is thought to selectively stimulate unmyelinated C fibre afferent neurons and cause the release of substance P. Prolonged application of capsaicin reversibly depletes stores of substance P, and possibly other neurotransmitters, from sensory nerve endings. This reduces or abolishes the transmission of painful stimuli from the peripheral nerve fibres to the higher centres.There were many study on Capsaicin gel to confirm the effectiveness of capsaicin gel in many dosages. However, there has been no efficacy study on the capsaicin 0.0125% of the Thai produce "Capsika gel " before, therefore, this study is proposed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: 0.0125% Capsaicin gel "CAPSIKA gel"Capsaicin and placebo controlled,Cross-over design study |
| B | Placebo comparator | Drug: PlaceboCapsaicin and placebo controlled,Cross-over design study |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects who are capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Ambulatory nom pregnant females and males 40-<80 years of age.
- Subjects who withdraw pain medication or nutritional supplements for symptom relief for knee OA for a total of at least 15 days before screening visit 0.
- Pain at or below 80 mm on a 100 mm VAS in the index knee.
- A documented diagnosis of OA of the knee, or meeting American College of Rheumatology (ACR) clinical criteria for classification of idiopathic (primary) OA for at least 6 months prior to screening. If OA is presented in both knees the investigator will identify which knee will be X-rayed for study entry, with preference for the knee with more severe pain (<80mm VAS).
Key exclusion criteria (10 listed)
- Subjects with history of hypersensitivity to capsaicin.
- Subjects with skin lesion at the index knee.
- A history of lower extremity surgery within 6 months prior to screening V0.
- Significant prior injury to the index knee within 12 months prior to screening V0.
- Disease of the spine or other lower extremity joints of sufficient degree to affect the index knee.
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 |
|---|---|---|
| 0.0125% Capsaicin gel "CAPSIKA gel" | Drug | A |
| PlaceboPlacebo | Drug | B |
Primary outcome
VAS and WOMAC
Time frame: 8 months
VAS and WOMAC
Time frame: 8-month study
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 9 Jul 2008.
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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.
weerachai Kosuwon, M.D principal investigator
Department of Orthopedics, Faculty of Medicine, Khon kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 0.0125% Capsaicin gel "CAPSIKA gel" in people with Osteoarthritis, Knee Joint and Capsicum, run by Khon Kaen University at 1 site in Thailand.
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 10 inclusion and 10 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 9 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
VAS and WOMAC (time frame: 8 months). The study lists 2 primary outcomes in all. 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 9 Jul 2008.