Assessment of the Safety and Efficacy of 3VM1001 Cream for Treatment of Chronic Pain Caused by Knee Osteoarthritis.

NCT02332148 | Unknown Phase 1

• 1 other identifier: 3VM0115
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Osteoarthritis of Knee

Outcome Measures

Primary Outcomes (1)

• Time-averaged change in pain from baseline in a standard visual analog scale

  baseline and 30 days

Study Arms (2)

3Vm1001

EXPERIMENTAL

3VM1001 topical cream containing 10 mg/day of copper, for 30 days

Drug: 3VM1001

Placebo

PLACEBO COMPARATOR

Placebo for 3VM1001, topical cream without 3VM1001

Drug: Placebo for 3VM1001

Interventions

3VM1001 DRUG

3VM1001 topical cream for treatment of osteoarthritis of the knee

3Vm1001

Placebo for 3VM1001 DRUG

Topical cream placebo for 3VM1001; cream without 3VM1001

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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
• 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:

Sponsors & Collaborators

• CDA Research Group, Inc.: lead
• 3VM Research Group, Inc.: collaborator

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: January 6, 2015
• Study Start: February 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: March 1, 2016
• Last Updated: August 21, 2015

Record last verified: 2015-08