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

Pain Clinical Trial

Official title:

Randomized, Double Blind, Placebo Controlled Crossover Trial With Open Label Extension Of Topical 20% Beta Caryophyllene Alone And In Combination With 0.025% Capsaicin In The Treatment Of Pain Caused By Osteoarthritis Of The Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03152578
• Other study ID #: PANAG-001
• Status: Completed
• Phase: Phase 2
• Start date: July 1, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: January 2020
• Source: Panag Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Pain

Intervention

Other:
• BetaC + Capsaicin Topical Cream
BetaC + Capsacin Topical Cream applied to painful knee area 3 times per day.
• BetaC Topical Cream
BetaC Topical Cream Cream applied to painful knee area 3 times per day.
• Placebo Topical Cream
Placebo Cream applied to painful knee area 3 times per day.

Locations

Country	Name	City	State
Canada	QEII Health Sciences Centre	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Panag Pharma Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	BPI-Short Form		12 weeks
Secondary	Patient's Global Impression of Change		12 weeks