Topical Use of 20% Beta Caryophyllene Alone And In Combination With 0.025% Capsaicin for Pain Caused by Osteoarthritis Of The Knee

NCT03152578 | Completed Phase 2

• 1 other identifier: PANAG-001
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This study consists of a randomized, double-blind, placebo-controlled crossover trial with open label extension evaluating a topical natural health cream containing ß-caryophyllene alone and in combination with 0.025% capsicum oleoresin against placebo. At the end of the randomized controlled phase of the trial all participants will be given open-label combination cream to be administered over the subsequent 3 weeks. Primary Endpoint: Evaluation of improvement in pain interference as measured by the BPI in individuals who are experiencing pain due to osteoarthritis of the knee. Secondary Endpoints: Secondary endpoints are: Confirmation of safety of the topical cream when used daily over 10 weeks. Further evaluation will include overall patient satisfaction with the products tested.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Pain Score Diary

  Change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to post treatment

  2 weeks

Secondary Outcomes (2)

• BPI-Short Form

  12 weeks

• Patient's Global Impression of Change

  12 weeks

Study Arms (3)

BetaC + Capsacian

ACTIVE COMPARATOR

1-3 mls BetaC + Capsacian applied to the painful areas, once upon awakening, once mid day and once before bed-time, each day for two (2) weeks.

Other: BetaC + Capsaicin Topical Cream

BetaC Only

ACTIVE COMPARATOR

1-3 mls BetaC applied to the painful areas, once upon awakening, once mid day and once before bed-time, each day for two (2) weeks.

Other: BetaC Topical Cream

Placebo

PLACEBO COMPARATOR

1-3 mls Placebo applied to the painful areas, once upon awakening, once mid day and once before bed-time, each day for two (2) weeks.

Other: Placebo Topical Cream

Interventions

BetaC + Capsaicin Topical Cream OTHER

BetaC + Capsacin Topical Cream applied to painful knee area 3 times per day.

BetaC + Capsacian

BetaC Topical Cream OTHER

BetaC Topical Cream Cream applied to painful knee area 3 times per day.

BetaC Only

Placebo Topical Cream OTHER

Placebo Cream applied to painful knee area 3 times per day.

Placebo

Eligibility Criteria

• Age: 18 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 criteria: Knee pain with 3 of the following:
• 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 (e.g. 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 using other topical agents for treatment of pain or inflammation
• Use of glucosamine, methysulfonylmethane or other regular anti-inflammatories within 2 weeks prior to completing baseline pain measure and during the trial
• Presence of significant medical disorder that would compromise the participant's safety to take part in the trial (e.g. cancer, immunosuppressed)
• Pregnant and breastfeeding women.
• Type I or Type II diabetes and other endocrine disorders
• Use of exercise or transcutaneous electrical nerve stimulation prior to and during the trial
• A history or present disease (i.e. inflammatory, infectious joint disease) which may affect the outcome of the trial
• Currently taking NHPs for joint health
• Currently enrolled in other clinical trial involving a pharmaceutical treatment

Sponsors & Collaborators

• Panag Pharma Inc.: lead

Study Sites (1)

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 15, 2017
• Study Start: July 1, 2017
• Primary Completion: June 30, 2019
• Study Completion: July 31, 2019
• Last Updated: January 6, 2020

Record last verified: 2020-01

Locations

CA (1)