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

• ClinicalTrials.gov Identifier: NCT03152578
• Recruitment Status: Completed
• First Posted: May 15, 2017
• Last Update Posted: January 6, 2020
• Sponsor: Panag Pharma Inc.
• Information provided by (Responsible Party): Panag Pharma Inc.

Tracking Information

• First Submitted Date: May 11, 2017
• First Posted Date: May 15, 2017
• Last Update Posted Date: January 6, 2020
• Actual Study Start Date: July 1, 2017
• Actual Primary Completion Date: June 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 11, 2017)

Pain Score Diary [ Time Frame: 2 weeks ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 11, 2017)

• BPI-Short Form [ Time Frame: 12 weeks ]
• Patient's Global Impression of Change [ Time Frame: 12 weeks ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Pain

Intervention

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

Study Arms

• Active Comparator: 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.
  Intervention: Other: BetaC + Capsaicin Topical Cream
• Active Comparator: 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.
  Intervention: Other: BetaC Topical Cream
• Placebo Comparator: 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.
  Intervention: Other: Placebo Topical Cream

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 11, 2017): 56
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 31, 2019
• Actual Primary Completion Date: June 30, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT03152578
• Other Study ID Numbers: PANAG-001
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Panag Pharma Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Panag Pharma Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Panag Pharma Inc.
• Verification Date: January 2020