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

NCT ID: NCT03152578

Last Updated: 2020-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2019-07-31

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

Study Design

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

Study Groups

BetaC + Capsacian

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.

Group Type: ACTIVE_COMPARATOR

BetaC + Capsaicin Topical Cream

Intervention Type: OTHER

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

BetaC Only

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.

Group Type: ACTIVE_COMPARATOR

BetaC Topical Cream

Intervention Type: OTHER

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

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo Topical Cream

Intervention Type: OTHER

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

Interventions

BetaC + Capsaicin Topical Cream

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

Intervention Type: OTHER

BetaC Topical Cream

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

Intervention Type: OTHER

Placebo Topical Cream

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Panag Pharma Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Countries

Canada

Other Identifiers

PANAG-001

Identifier Type: -

Identifier Source: org_study_id