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3VM for Treatment of Chronic Osteoarthritis Knee Pain

NCT03142178 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2018-07-06

No results posted yet for this study

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

Interventions

DRUG

Experimental: 3VM1001 active 2g Cream 3 times daily

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

DRUG

Experimental: 3VM1001 active 3g Cream 3 times daily

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

DRUG

Experimental: 3VM1001 active 3g Cream 4 times daily

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

DRUG

Placebo: 3VM1001 vehicle 2g Cream 3 times daily

3VM1001 placebo 2g vehicle Cream administered 3 times daily

DRUG

Placebo: 3VM1001 vehicle 3g Cream 3 times daily

3VM1001 placebo 3g vehicle Cream administered 3 times daily

DRUG

Placebo: 3VM1001 vehicle 3g Cream 4 times daily

3VM1001 placebo 3g vehicle Cream administered 4 times daily

Sponsors & Collaborators

  • CDA Research Group, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-30
Primary Completion
2018-01-30
Completion
2018-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03142178 on ClinicalTrials.gov