Topical Use of 20% Beta Caryophyllene Alone And In Combination With 0.025% Capsaicin for Pain Caused by Osteoarthritis Of The Knee
Primary Purpose
Pain
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
BetaC + Capsaicin Topical Cream
BetaC Topical Cream
Placebo Topical Cream
Sponsored by
About this trial
This is an interventional treatment trial for Pain
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
Sites / Locations
- QEII Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
BetaC + Capsacian
BetaC Only
Placebo
Arm 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.
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.
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.
Outcomes
Primary Outcome Measures
Pain Score Diary
Change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to post treatment
Secondary Outcome Measures
BPI-Short Form
Patient's Global Impression of Change
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03152578
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Panag Pharma Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BetaC + Capsacian
Arm Type
Active Comparator
Arm 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.
Arm Title
BetaC Only
Arm Type
Active Comparator
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
BetaC + Capsaicin Topical Cream
Intervention Description
BetaC + Capsacin Topical Cream applied to painful knee area 3 times per day.
Intervention Type
Other
Intervention Name(s)
BetaC Topical Cream
Intervention Description
BetaC Topical Cream Cream applied to painful knee area 3 times per day.
Intervention Type
Other
Intervention Name(s)
Placebo Topical Cream
Intervention Description
Placebo Cream applied to painful knee area 3 times per day.
Primary Outcome Measure Information:
Title
Pain Score Diary
Description
Change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to post treatment
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
BPI-Short Form
Time Frame
12 weeks
Title
Patient's Global Impression of Change
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
QEII Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Topical Use of 20% Beta Caryophyllene Alone And In Combination With 0.025% Capsaicin for Pain Caused by Osteoarthritis Of The Knee
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