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

NCT02193711 | Completed Phase 3

• 1 other identifier: Delivra-001
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Change in mean daily pain diary score from baseline

  The primary outcome measure will consist of change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to the final 3 days of the third treatment week. Therefore, the primary analysis is a between group comparison (placebo versus test product) over 3 weeks.

  three weeks

Secondary Outcomes (4)

• WOMAC

  Six weeks

• BPI-SF

  six weeks

• PGIC

  six weeks

• PGSS

  six weeks

Study Arms (2)

Topical Arthritis Cream

EXPERIMENTAL

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.

Other: Topical Arthritis Cream

Placebo

PLACEBO COMPARATOR

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.

Other: Topical Arthritis Cream

Interventions

Topical Arthritis Cream OTHER

Also known as: LivRelief Pharmax Rebuild

Placebo; Topical Arthritis Cream

Eligibility Criteria

• Age: 18 Years - 100 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 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Delivra, Inc.: lead

Study Sites (2)

CDHA - Pain Management Unit

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Canadian College of Naturopathic Medicine

Toronto, Ontario, M2K 1E2, Canada

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: July 18, 2014
• Study Start: January 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 1, 2018

Record last verified: 2018-01

Locations

CA (2)