Delivra Joint Health Cream In The Treatment Of Pain Caused By Osteoarthritis Of The Knee

NCT ID: NCT02193711

Last Updated: 2018-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-12-31

Brief Summary

The current clinical trial is designed to test the analgesic and anti-inflammatory efficacy of a topical cream compared to a placebo cream. The study population will be those with mild to moderate osteoarthritis of the knee.

The trial will also provide information about potential side effects and verify the safety of this composition. Blood levels will be done to assess inflammation and to determine whether any systemic absorption has occurred.

Hypothesis/Purpose

• Pain scores after active treatment will be significantly reduced in comparison to placebo.
• There will be an improvement in stiffness and physical function as measured by the WOMAC using the active cream as compared to placebo.
• There will be a decrease in the level of inflammation assessed at baseline, end of week 3 and end of week 6.
• The blood concentration of the active ingredient in the topical cream will not exceed the maximum daily dose that will be consumed by participants.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Topical Arthritis Cream

1-1.5 ml applied to the skin over the knee in the morning and at bedtime over the entire study period, for a total of 2-3 ml/day.

Group Type: EXPERIMENTAL

Topical Arthritis Cream

Intervention Type: OTHER

Placebo

1-1.5 ml applied to the skin over the knee in the morning and at bedtime over the entire study period, for a total of 2-3 ml/day.

Group Type: PLACEBO_COMPARATOR

Topical Arthritis Cream

Intervention Type: OTHER

Interventions

Topical Arthritis Cream

Intervention Type: OTHER

Other Intervention Names

LivRelief Pharmax Rebuild

Eligibility Criteria

Inclusion Criteria

• Osteoarthritis of the knee according to American College of Rheumatology criteria: Knee pain with 3:

• age >50 years
• stiffness less than 30 min
• crepitus,
• bony tenderness,
• bony enlargement,
• no palpable warmth
• Moderate to severe pain, as defined by an average 7-day pain score of greater than 4.0 on an 11-point numerical rating scale for pain intensity (NRS-PI).
• 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
• Willing and able to give informed consent

Exclusion Criteria

• Currently taking opioids, NSAIDs, warfarin, other anticoagulants, other topical agents for treatment of pain or inflammation
• Allergy to tea tree oil, latex, avocado, soy
• Active conditions such as exzema or psoriasis
• Presence of significant medical disorder that would compromise the participant's safety to take part in the trial (eg. cancer, immunosuppressed)
• Individuals with a history or current disease which may affect the outcome of the trial (ie. Inflammatory, infections joint disease).
• Allergy to plants of the Asteraceae/Compositae/Daisy family.
• Pregnant and breastfeeding women.
• Allergy or other contraindication for acetaminophen use.
• Exercise or transcutaneous electrical nerve stimulation should be excluded prior to and during the trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Delivra, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CDHA - Pain Management Unit

Halifax, Nova Scotia, Canada

Canadian College of Naturopathic Medicine

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

Delivra-001

Identifier Type: -

Identifier Source: org_study_id