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

Panag Pharma

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Other: BetaC Topical Cream; Other: Placebo Topical Cream; Other: BetaC + Capsaicin Topical Cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT03152578

PANAG-001

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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56 participants in 3 patient groups, including a placebo group

BetaC + Capsacian

Active Comparator group

Description:

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.

Treatment:

Other: BetaC + Capsaicin Topical Cream

BetaC Only

Active Comparator group

Description:

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.

Treatment:

Other: BetaC Topical Cream

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo Topical Cream