3VM for Treatment of Chronic Osteoarthritis Knee Pain

NCT03142178 | Completed Phase 1 FDA Drug

• 1 other identifier: 3VM1216
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arthritis, Degenerative

Keywords

osteoarthritis; pain; knee

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days

Secondary Outcomes (6)

• Adverse events, Serious adverse events, and study discontinuation

  8 days

• Patient global impression of change scale (PGIC) from baseline to end of study period.

  8 days

• Change in the global rating of disease for 3VM1001 Cream and placebo from baseline to the end of study.

  8 days

• Patient Global Impression of change from baseline in Osteoarthritis (OA) pain..

  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.

  8 days

Study Arms (6)

Experimental 3VM1001 2g X 3 daily

EXPERIMENTAL

3VM1001 active cream administered 2g cream three times daily for seven days

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

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

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

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

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

Drug: Placebo: 3VM1001 vehicle 3g Cream 4 times daily

Interventions

Experimental: 3VM1001 active 2g Cream 3 times daily DRUG

3VM1001 2g Cream with active ingredient administered 3 times daily

Experimental 3VM1001 2g X 3 daily

Experimental: 3VM1001 active 3g Cream 3 times daily DRUG

3VM1001 3g Cream with active ingredient administered 3 times daily

Experimental 3VM1001 3g X 3 daily

Experimental: 3VM1001 active 3g Cream 4 times daily DRUG

3VM1001 3g Cream with active ingredient administered 4 times daily

Experimental 3VM1001 3g x 4 daily

Placebo: 3VM1001 vehicle 2g Cream 3 times daily DRUG

3VM1001 placebo 2g vehicle Cream administered 3 times daily

Placebo; 3VM1001 vehicle 2g X 3 daily

Placebo: 3VM1001 vehicle 3g Cream 3 times daily DRUG

3VM1001 placebo 3g vehicle Cream administered 3 times daily

Placebo; 3VM1001 vehicle 3g X3 daily

Placebo: 3VM1001 vehicle 3g Cream 4 times daily DRUG

3VM1001 placebo 3g vehicle Cream administered 4 times daily

Placebo; 3VM1001 vehicle 3g X 4 daily

Eligibility Criteria

• Age: 40 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. 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.
• 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

You may not qualify if:

• 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.
• 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:

Sponsors & Collaborators

• CDA Research Group, Inc.: lead

Study Sites (1)

Optimed Research, LTD

Columbus, Ohio, 43235, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participant, Investigator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, placebo controlled, randomized

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 5, 2017
• Study Start: April 30, 2017
• Primary Completion: January 30, 2018
• Study Completion: June 1, 2018
• Last Updated: July 6, 2018

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)