Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
150 participants
INTERVENTIONAL
2017-04-30
2018-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Assessment of the Safety and Efficacy of 3VM1001 Cream for Treatment of Chronic Pain Caused by Knee Osteoarthritis.
NCT02332148
A Study to Evaluate the Analgesic Efficacy and Safety of VM902A in Subjects With Osteoarthritis (OA) of the Knee
NCT02847702
Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study In Subjects With Osteoarthritic Pain Of The Knee
NCT00689273
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 403 in Subjects With Osteoarthritis Knee Pain
NCT02318407
Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis (OA) of the Knee
NCT01688934
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental 3VM1001 2g X 3 daily
3VM1001 active cream administered 2g cream three times daily for seven days
Experimental: 3VM1001 active 2g Cream 3 times daily
3VM1001 2g Cream with active ingredient administered 3 times daily
Placebo; 3VM1001 vehicle 2g X 3 daily
3VM1001 placebo vehicle administered 2g cream three times daily for seven days
Placebo: 3VM1001 vehicle 2g Cream 3 times daily
3VM1001 placebo 2g vehicle Cream administered 3 times daily
Experimental 3VM1001 3g X 3 daily
3VM1001 active cream administered 3g cream three times daily for seven days
Experimental: 3VM1001 active 3g Cream 3 times daily
3VM1001 3g Cream with active ingredient administered 3 times daily
Placebo; 3VM1001 vehicle 3g X3 daily
3VM1001 placebo vehicle administered 3g cream three times daily for seven day
Placebo: 3VM1001 vehicle 3g Cream 3 times daily
3VM1001 placebo 3g vehicle Cream administered 3 times daily
Experimental 3VM1001 3g x 4 daily
3VM1001 active cream administered 3g cream four times daily for seven days
Experimental: 3VM1001 active 3g Cream 4 times daily
3VM1001 3g Cream with active ingredient administered 4 times daily
Placebo; 3VM1001 vehicle 3g X 4 daily
3VM1001 placebo vehicle administered 3g cream four times daily for seven days
Placebo: 3VM1001 vehicle 3g Cream 4 times daily
3VM1001 placebo 3g vehicle Cream administered 4 times daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Experimental: 3VM1001 active 2g Cream 3 times daily
3VM1001 2g Cream with active ingredient administered 3 times daily
Experimental: 3VM1001 active 3g Cream 3 times daily
3VM1001 3g Cream with active ingredient administered 3 times daily
Experimental: 3VM1001 active 3g Cream 4 times daily
3VM1001 3g Cream with active ingredient administered 4 times daily
Placebo: 3VM1001 vehicle 2g Cream 3 times daily
3VM1001 placebo 2g vehicle Cream administered 3 times daily
Placebo: 3VM1001 vehicle 3g Cream 3 times daily
3VM1001 placebo 3g vehicle Cream administered 3 times daily
Placebo: 3VM1001 vehicle 3g Cream 4 times daily
3VM1001 placebo 3g vehicle Cream administered 4 times daily
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
* 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
Exclusion Criteria
* 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.
* 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:
1. Devices of therapeutics for knee pain or ambulation
2. Analgesics other than acetaminpohen
3. Systemic or locally injected corticosteroids
4. Other investigational drugs
5. Chemotherapy drugs
6. Immunotherapy
7. Topical products applied to he target knee
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
CDA Research Group, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Optimed Research, LTD
Columbus, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
3VM1216
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.