Osteoarthritis of KneePhase 1NCT02332148
Assessment of the Safety and Efficacy of 3VM1001 Cream for Treatment of Chronic Pain Caused by Knee Osteoarthritis.
A Phase 1 study testing 3VM1001 in people with Osteoarthritis of Knee, run by CDA Research Group, Inc..
Trial summary
3VM1001 is a topical cream that may be useful for the treatment of chronic osteoarthritis of the knee. This proof of concept study is a randomized, placebo-controlled, double-blind study to compare treatment with 3VM1001 cream to an inactive cream placebo. Subjects will self-treat for 30 days. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis of Knee
- What is being tested?
- 3VM1001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Mar 2016
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthritis of the knee according to American College of Rheumatology clinical radiological criteria;
- OA of knee ≥ 6 months prior to screening;
- age 40 years or older;
- subjects of childbearing potential and their partners must use effective contraception;
- women of childbearing age must have a negative pregnancy test or screening or be using an acceptable form of birth control;
- moderate to severe chronic OA pain defined as POM score between 40 mm and 90 mm;
Show all 12Show fewer
- baseline WOMAC pain subscale score ≥ 9;
- no change in physical activity and/or therapy for the past 3 months;- all concurrent medications taken for any reason stable for 14 days;
- ability to follow protocol with reference to cognitive and situational factors (eg. stable housing, ability to attend visits;
- ability to read and write English;
- ability to apply cream without assistance;
- able to provide written informed consent.
Who cannot join
- Presence of significant medical disorder that would compromise the participant's safety to take part in the trial (e.g. cancer, immunosuppressed) or evidence of alcohol or substance abuse;
- Wilson's disease or other disorder of copper metabolism
- BMI >35
- Known hypersensitivity or allergy to any component of the product, or to acetaminophen
- Pregnant and breastfeeding women
- Transcutaneous electrical nerve stimulation and use of crutches, walkers, or wheel chairs should be excluded prior to and during treatment
Show all 22Show fewer
- Active conditions over the area to be treated such as eczema or psoriasis, compromised integrity of the intact, superficial skin layer over the area to be treated.
- Pain in any joint other than the index joint that could interfere with the patient's assessment of pain in the index joint
- Recent injury (traumatic or sports related) to either knee causing pain and interference with daily activities (e.g. walking)
- Recent surgery/procedure to either knee causing pain that could interfere with study assessments of pain, function, and QoL.
- Extreme pain in the target knee characterized by POM score of >90 mm
- Mild pain in the target knee, characterized by POM score of < 40 mm
- Open surgery of the target knee within the last year
- Arthroscopic surgery of the target knee within the last 3 months
- Use of prohibited concomitant medications/therapies during the 30-day treatment period including:
- devices or therapeutic treatments for knee pain or ambulation
- analgesics other than acetaminophen
- Systemic corticosteroids
- other investigational drugs
- chemotherapeutic drugs
- immunotherapy
- topical products applied to the target knee
About this study
Official title: A Double-blind, Placebo-controlled, Randomized Study to Assess the Safety and Efficacy of 3VM1001 Cream for the Treatment of Chronic Pain Caused by Osteoarthritis of the Knee: A Proof of Concept Study
3VM1001 is a topical cream that may be useful for the treatment of chronic osteoarthritis of the knee. This proof of concept study is a randomized, placebo-controlled, double-blind study to compare treatment with 3VM1001 cream to an inactive cream placebo. Subjects will self-treat for 30 days.
Read the detailed description
3VM1001 is a topical cream that may be useful for the treatment of chronic osteoarthritis of the knee. This proof of concept study is a randomized, placebo-controlled, double-blind study to compare treatment with 3VM1001 cream to an inactive cream placebo. Subjects will self-treat for 30 days with investigational drug or placebo. Rescue medication with acetaminophen, up to 2g daily, is permitted. This study is intended to evaluate the safety and efficacy of 3VM1001 topical cream, a copper-containing cream. Subjects will self treat with drug or placebo three times daily for 30 days. All subjects will have a total of three visits to the clinic and will complete a daily diary each day for the 30 days of treatment.
- Conditions
- Osteoarthritis of Knee
- Being tested
- 3VM1001, Placebo for 3VM1001
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3VM1001Drug
3VM1001 topical cream for treatment of osteoarthritis of the knee
Placebo for 3VM1001Drug
Topical cream placebo for 3VM1001; cream without 3VM1001
| Study group | Role | What they receive |
|---|---|---|
| 3Vm1001 | Experimental | 3VM1001 topical cream containing 10 mg/day of copper, for 30 days Receives: Drug: 3VM1001 |
| Placebo | Placebo comparator | Placebo for 3VM1001, topical cream without 3VM1001 Receives: Drug: Placebo for 3VM1001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-averaged change in pain from baseline in a standard visual analog scale
Measured: baseline and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionOct 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CDA Research Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3VM Research Group, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332148
- Sponsor's protocol ID
- 3VM0115
- Status last verified
- Aug 2015
- First submitted
- 5 Jan 2015
- Last updated
- 21 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomized Study to Assess the Safety and Efficacy of 3VM1001 Cream for the Treatment of Chronic Pain Caused by Osteoarthritis of the Knee: A Proof of Concept Study
- ClinicalTrials.gov ID
- NCT02332148
- Acronym / sponsor ID
- 3VM0115
- Conditions
- Osteoarthritis of Knee
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- CDA Research Group, Inc.Industry (pharma, biotech, devices)
- Collaborators
- 3VM Research Group, Inc.
- Study start
- Feb 2015
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 6 Jan 2015 (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.
3VM1001 is a topical cream that may be useful for the treatment of chronic osteoarthritis of the knee. This proof of concept study is a randomized, placebo-controlled, double-blind study to compare treatment with 3VM1001 cream to an inactive cream placebo. Subjects will self-treat for 30 days.
Detailed description
3VM1001 is a topical cream that may be useful for the treatment of chronic osteoarthritis of the knee. This proof of concept study is a randomized, placebo-controlled, double-blind study to compare treatment with 3VM1001 cream to an inactive cream placebo. Subjects will self-treat for 30 days with investigational drug or placebo. Rescue medication with acetaminophen, up to 2g daily, is permitted. This study is intended to evaluate the safety and efficacy of 3VM1001 topical cream, a copper-containing cream. Subjects will self treat with drug or placebo three times daily for 30 days. All subjects will have a total of three visits to the clinic and will complete a daily diary each day for the 30 days of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3Vm1001 | Experimental | Drug: 3VM10013VM1001 topical cream containing 10 mg/day of copper, for 30 days |
| Placebo | Placebo comparator | Drug: Placebo for 3VM1001Placebo for 3VM1001, topical cream without 3VM1001 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Osteoarthritis of the knee according to American College of Rheumatology clinical radiological criteria;
- OA of knee ≥ 6 months prior to screening;
- age 40 years or older;
- subjects of childbearing potential and their partners must use effective contraception;
- women of childbearing age must have a negative pregnancy test or screening or be using an acceptable form of birth control;
Key exclusion criteria (22 listed)
- Presence of significant medical disorder that would compromise the participant's safety to take part in the trial (e.g. cancer, immunosuppressed) or evidence of alcohol or substance abuse;
- Wilson's disease or other disorder of copper metabolism
- BMI >35
- Known hypersensitivity or allergy to any component of the product, or to acetaminophen
- Pregnant and breastfeeding women
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 |
|---|---|---|
| 3VM10013VM1001 topical cream for treatment of osteoarthritis of the knee | Drug | 3Vm1001 |
| Placebo for 3VM1001Topical cream placebo for 3VM1001; cream without 3VM1001 | Drug | Placebo |
Primary outcome
Time-averaged change in pain from baseline in a standard visual analog scale
Time frame: baseline and 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2015.
Related trials for Osteoarthritis of Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 3VM1001 in people with Osteoarthritis of Knee, run by CDA Research Group, Inc..
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 12 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 21 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Time-averaged change in pain from baseline in a standard visual analog scale (time frame: baseline and 30 days). 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 21 Aug 2015.