Arthritis, DegenerativePhase 1/2NCT03142178
3VM for Treatment of Chronic Osteoarthritis Knee Pain
A Phase 1/2 study testing Experimental: 3VM1001 active 2g Cream 3 times daily, Experimental: 3VM1001 active 3g Cream 3 times daily and Experimental: 3VM1001 active 3g Cream 4 times daily in people with Arthritis, Degenerative, run by CDA Research Group, Inc. at 1 site in United States.
Trial summary
A double-blind, placebo-controlled, randomized dose ranging study for the use of 3VM1001 Cream, 2g three times daily, 3g three times daily, or 3g four times daily for treatment of chronic pain associated with osteoarthritis of the knee compared to inactive placebo. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Arthritis, Degenerative
- What is being tested?
- Experimental: 3VM1001 active 2g Cream 3 times daily, Experimental: 3VM1001 active 3g Cream 3 times daily and Experimental: 3VM1001 active 3g Cream 4 times daily
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2017to 1 Jun 2018
- Phase
- Phase 1/2
- 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 years and older
- 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. A knee radiograph will be ordered and reviewed.
- OA of the knee >/= 6 months prior to screening. Subjects with OA of both knees will treat the worst knee.
- Age 40 years or older
- Males or females of non-childbearing potential (12 or more months of spontaneous amenorrhea, bilateral oophorectomy at least 6 months prior to randomization, hysterectomy with bilateral oophorectomy at least 6 months prior to randomization, or for females over 50 years of age, hysterectomy without bilateral oophorectomy at least 6 months prior to randomization.; female subjects of childbearing potential must agree to use contraception (abstinence, birth control pills, rings or patches, diaphragm an spermicide, intrauterine device, condom and vaginal spermicide, surgical sterilization, vasectomy, progestin implant or injection); female partners of childbearing potential of male subjects must agree to use contraception as defined above.
- Moderate to severe OA pain defined a POM score between 40 mm and 90 mm.
- Baseline WOMAC pain subscale score >/=9.
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- 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 such as 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 study such as cancer, immunosuppressed, or evidence of alcohol or substance abuse.
- Wilson's disease or other disorder of copper metabolism.
- BMI >40
- Known hypersensitivity or allergy to any component of the product, or to acetaminophen.
- Transcutaneous electrical nerve stimulation and use of crutches, walkers or wheel chairs should be excluded prior to and during treatment. Use of a cane is permitted.
- Active conditions over the area to be treated such a eczema or psoriasis, compromised integrity of the intact, superficial skin layer over the area to be treated.
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- Pain in any joint being studied that could interfere with the subject's assessment of pain in the index joint.
- Recent (within 12 months) injury (traumatic or sports related) to either knee causing pain and interference with daily activities such as walking.
- Recent (within 12 months) surgery/procedure (including intra-articular injection) 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 </= 40 mm.
- Mild pain in the target knee characterized by POM score of </= 40 mm.
- Open surgery of he target knee within the last year.
- Significant concomitant disease of the knee to be studied such as fracture or osteonecrosis.
- Arthroscopic surgery of the target knee within the last 3 months.
- Use of prohibited medications/therapies during he 7-9 day treatment period including:
- Devices of therapeutics for knee pain or ambulation
- Analgesics other than acetaminpohen
- Systemic or locally injected corticosteroids
- Other investigational drugs
- Chemotherapy drugs
- Immunotherapy
- Topical products applied to he target knee
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Safety and Efficacy of 3VM1001 Cream for the Treatment of Chronic Pain Caused by Osteoarthritis of the Knee: A Dose Ranging Study
A double-blind, placebo-controlled, randomized dose ranging study for the use of 3VM1001 Cream, 2g three times daily, 3g three times daily, or 3g four times daily for treatment of chronic pain associated with osteoarthritis of the knee compared to inactive placebo.
Read the detailed description
The study is a double-blind, placebo-controlled, dose ranging study for the use of 3VM1001 Cream, 2g three times daily, 3g three times daily, or 3g four times daily for the treatment of chronic pain associated with osteoarthritis of the knee compared to the inactive vehicle as a placebo.
A maximum of 120 subjects will be enrolled. Subjects will self-treat for 7 (+2) days, applied in the morning and at bed time.
The active pharmaceutical ingredient is copper. The proposed doses in the study are less than 2% of the upper limit of the RDA (0.9 mg/day, upper limit 10mg/day).
Rescue medication is acetaminophen, up to ~2g daily (Up to six Tylenol Regular Strength tablets).
- Conditions
- Arthritis, Degenerative
- Being tested
- Experimental: 3VM1001 active 2g Cream 3 times daily, Experimental: 3VM1001 active 3g Cream 3 times daily, Experimental: 3VM1001 active 3g Cream 4 times daily, Placebo: 3VM1001 vehicle 2g Cream 3 times daily, Placebo: 3VM1001 vehicle 3g Cream 3 times daily
- Keywords
- osteoarthritis, pain, knee
- Medical subject headings
- Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: 3VM1001 active 2g Cream 3 times dailyDrug
3VM1001 2g Cream with active ingredient administered 3 times daily
Experimental: 3VM1001 active 3g Cream 3 times dailyDrug
3VM1001 3g Cream with active ingredient administered 3 times daily
Experimental: 3VM1001 active 3g Cream 4 times dailyDrug
3VM1001 3g Cream with active ingredient administered 4 times daily
Placebo: 3VM1001 vehicle 2g Cream 3 times dailyDrug
3VM1001 placebo 2g vehicle Cream administered 3 times daily
Placebo: 3VM1001 vehicle 3g Cream 3 times dailyDrug
3VM1001 placebo 3g vehicle Cream administered 3 times daily
Placebo: 3VM1001 vehicle 3g Cream 4 times dailyDrug
3VM1001 placebo 3g vehicle Cream administered 4 times daily
| Study group | Role | What they receive |
|---|---|---|
| Experimental 3VM1001 2g X 3 daily | Experimental | 3VM1001 active cream administered 2g cream three times daily for seven days Receives: Drug: Experimental: 3VM1001 active 2g Cream 3 times daily |
| Placebo; 3VM1001 vehicle 2g X 3 daily | Placebo comparator | 3VM1001 placebo vehicle administered 2g cream three times daily for seven days Receives: Drug: Placebo: 3VM1001 vehicle 2g Cream 3 times daily |
| Experimental 3VM1001 3g X 3 daily | Experimental | 3VM1001 active cream administered 3g cream three times daily for seven days Receives: Drug: Experimental: 3VM1001 active 3g Cream 3 times daily |
| Placebo; 3VM1001 vehicle 3g X3 daily | Placebo comparator | 3VM1001 placebo vehicle administered 3g cream three times daily for seven day Receives: Drug: Placebo: 3VM1001 vehicle 3g Cream 3 times daily |
| Experimental 3VM1001 3g x 4 daily | Experimental | 3VM1001 active cream administered 3g cream four times daily for seven days Receives: Drug: Experimental: 3VM1001 active 3g Cream 4 times daily |
| Placebo; 3VM1001 vehicle 3g X 4 daily | Placebo comparator | 3VM1001 placebo vehicle administered 3g cream four times daily for seven days Receives: Drug: Placebo: 3VM1001 vehicle 3g Cream 4 times daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time averaged change from baseline in a standard 100 mm Visual Analog Scale (VAS).
The time-averaged mean of all patient pain scores over each study period.
Measured: 7 days
Secondary outcomes (6)
Adverse events, Serious adverse events, and study discontinuation
Collection of Adverse events, Serious adverse events, and study discontinuation over each study period.
Measured: 8 days
Patient global impression of change scale (PGIC) from baseline to end of study period.
This measure is a single-item rating by participants of their improvement with treatment on a 7-point scale that ranges from "very much improved" to "very much worse" with a mid-point of "no-change".
Measured: 8 days
Change in the global rating of disease for 3VM1001 Cream and placebo from baseline to the end of study.
Change in the global rating of disease for 3VM1001 Cream and placebo from baseline to day 8 measured on a 5-point Likert scale, with numerical values recorded by the subjects.
Measured: 8 days
Patient Global Impression of change from baseline in Osteoarthritis (OA) pain..
Subjects will rate their overall satisfaction from baseline (Day 0) to the end of study using a 6-point categorical sale from "very much worse"(0) to "very satisfied" (6).
Measured: From screening Day 0 to the end of study (8 days)
Change in Patient Global Assessment of Treatment Satisfaction from baseline to end of study.
Subjects will rate their overall satisfaction with study treatment using a 5-point categorical sccale from "dissatisfied" (0) to "very satisfied" (4)
Measured: 8 days
Use of rescue medication
The use of rescue medication for pain
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start30 Apr 2017
- Primary completion30 Jan 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, DegenerativeStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, placebo controlled, randomized
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- CDA Research Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142178
- Sponsor's protocol ID
- 3VM1216
- Status last verified
- Apr 2017
- First submitted
- 27 Apr 2017
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Safety and Efficacy of 3VM1001 Cream for the Treatment of Chronic Pain Caused by Osteoarthritis of the Knee: A Dose Ranging Study
- ClinicalTrials.gov ID
- NCT03142178
- Acronym / sponsor ID
- 3VM1216
- Conditions
- Arthritis, Degenerative
- Keywords
- osteoarthritis, pain, knee
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- CDA Research Group, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 5 May 2017 (actual)
- 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.
A double-blind, placebo-controlled, randomized dose ranging study for the use of 3VM1001 Cream, 2g three times daily, 3g three times daily, or 3g four times daily for treatment of chronic pain associated with osteoarthritis of the knee compared to inactive placebo.
Detailed description
The study is a double-blind, placebo-controlled, dose ranging study for the use of 3VM1001 Cream, 2g three times daily, 3g three times daily, or 3g four times daily for the treatment of chronic pain associated with osteoarthritis of the knee compared to the inactive vehicle as a placebo.
A maximum of 120 subjects will be enrolled. Subjects will self-treat for 7 (+2) days, applied in the morning and at bed time.
The active pharmaceutical ingredient is copper. The proposed doses in the study are less than 2% of the upper limit of the RDA (0.9 mg/day, upper limit 10mg/day).
Rescue medication is acetaminophen, up to ~2g daily (Up to six Tylenol Regular Strength tablets).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
- Model description
- Double-blind, placebo controlled, randomized
| Arm | Type | Receives |
|---|---|---|
| Experimental 3VM1001 2g X 3 daily | Experimental | Drug: Experimental: 3VM1001 active 2g Cream 3 times daily3VM1001 active cream administered 2g cream three times daily for seven days |
| Placebo; 3VM1001 vehicle 2g X 3 daily | Placebo comparator | Drug: Placebo: 3VM1001 vehicle 2g Cream 3 times daily3VM1001 placebo vehicle administered 2g cream three times daily for seven days |
| Experimental 3VM1001 3g X 3 daily | Experimental | Drug: Experimental: 3VM1001 active 3g Cream 3 times daily3VM1001 active cream administered 3g cream three times daily for seven days |
| Placebo; 3VM1001 vehicle 3g X3 daily | Placebo comparator | Drug: Placebo: 3VM1001 vehicle 3g Cream 3 times daily3VM1001 placebo vehicle administered 3g cream three times daily for seven day |
| Experimental 3VM1001 3g x 4 daily | Experimental | Drug: Experimental: 3VM1001 active 3g Cream 4 times daily3VM1001 active cream administered 3g cream four times daily for seven days |
| Placebo; 3VM1001 vehicle 3g X 4 daily | Placebo comparator | Drug: Placebo: 3VM1001 vehicle 3g Cream 4 times daily3VM1001 placebo vehicle administered 3g cream four times daily for seven days |
Who may qualify
- Ages
- 40 years and older
- 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. A knee radiograph will be ordered and reviewed.
- OA of the knee >/= 6 months prior to screening. Subjects with OA of both knees will treat the worst knee.
- Age 40 years or older
- Males or females of non-childbearing potential (12 or more months of spontaneous amenorrhea, bilateral oophorectomy at least 6 months prior to randomization, hysterectomy with bilateral oophorectomy at least 6 months prior to randomization, or for females over 50 years of age, hysterectomy without bilateral oophorectomy at least 6 months prior to randomization.; female subjects of childbearing potential must agree to use contraception (abstinence, birth control pills, rings or patches, diaphragm an spermicide, intrauterine device, condom and vaginal spermicide, surgical sterilization, vasectomy, progestin implant or injection); female partners of childbearing potential of male subjects must agree to use contraception as defined above.
- Moderate to severe OA pain defined a POM score between 40 mm and 90 mm.
Key exclusion criteria (22 listed)
- Presence of significant medical disorder that would compromise the participant's safety to take part in the study such as cancer, immunosuppressed, or evidence of alcohol or substance abuse.
- Wilson's disease or other disorder of copper metabolism.
- BMI >40
- Known hypersensitivity or allergy to any component of the product, or to acetaminophen.
- Transcutaneous electrical nerve stimulation and use of crutches, walkers or wheel chairs should be excluded prior to and during treatment. Use of a cane is permitted.
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 |
|---|---|---|
| Experimental: 3VM1001 active 2g Cream 3 times daily3VM1001 2g Cream with active ingredient administered 3 times daily | Drug | Experimental 3VM1001 2g X 3 daily |
| Experimental: 3VM1001 active 3g Cream 3 times daily3VM1001 3g Cream with active ingredient administered 3 times daily | Drug | Experimental 3VM1001 3g X 3 daily |
| Experimental: 3VM1001 active 3g Cream 4 times daily3VM1001 3g Cream with active ingredient administered 4 times daily | Drug | Experimental 3VM1001 3g x 4 daily |
| Placebo: 3VM1001 vehicle 2g Cream 3 times daily3VM1001 placebo 2g vehicle Cream administered 3 times daily | Drug | Placebo; 3VM1001 vehicle 2g X 3 daily |
| Placebo: 3VM1001 vehicle 3g Cream 3 times daily3VM1001 placebo 3g vehicle Cream administered 3 times daily | Drug | Placebo; 3VM1001 vehicle 3g X3 daily |
| Placebo: 3VM1001 vehicle 3g Cream 4 times daily3VM1001 placebo 3g vehicle Cream administered 4 times daily | Drug | Placebo; 3VM1001 vehicle 3g X 4 daily |
Primary outcome
Time averaged change from baseline in a standard 100 mm Visual Analog Scale (VAS).
Time frame: 7 days
The time-averaged mean of all patient pain scores over each study period.
6 secondary outcomes
Adverse events, Serious adverse events, and study discontinuation
Time frame: 8 days
Patient global impression of change scale (PGIC) from baseline to end of study period.
Time frame: 8 days
Change in the global rating of disease for 3VM1001 Cream and placebo from baseline to the end of study.
Time frame: 8 days
Patient Global Impression of change from baseline in Osteoarthritis (OA) pain..
Time frame: From screening Day 0 to the end of study (8 days)
Change in Patient Global Assessment of Treatment Satisfaction from baseline to end of study.
Time frame: 8 days
Use of rescue medication
Time frame: 8 days
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 6 Jul 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Experimental: 3VM1001 active 2g Cream 3 times daily, Experimental: 3VM1001 active 3g Cream 3 times daily and Experimental: 3VM1001 active 3g Cream 4 times daily in people with Arthritis, Degenerative, run by CDA Research Group, Inc. at 1 site in United States.
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: finished, as of the sponsor's last update on 6 Jul 2018. 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 United States. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Time averaged change from baseline in a standard 100 mm Visual Analog Scale (VAS). (time frame: 7 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 6 Jul 2018.