ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    panag [Lead]
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03152578
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
Panag Pharma Inc.

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.


Condition or disease Intervention/treatment Phase
Pain Other: BetaC + Capsaicin Topical Cream Other: BetaC Topical Cream Other: Placebo Topical Cream Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Capsaicin

Arm Intervention/treatment
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.
Other: BetaC + Capsaicin Topical Cream
BetaC + Capsacin Topical Cream applied to painful knee area 3 times per day.

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

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. BPI-Short Form [ Time Frame: 12 weeks ]
  2. Patient's Global Impression of Change [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03152578


Contacts
Contact: Sara Whynot 902-473-7449 sara@panagrx.com

Locations
Canada, Nova Scotia
QEII Health Sciences Centre Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Contact: Karim Mukhida, MD    902-473-5030    karim.mukhida@dal.ca   
Sponsors and Collaborators
Panag Pharma Inc.

Responsible Party: Panag Pharma Inc.
ClinicalTrials.gov Identifier: NCT03152578     History of Changes
Other Study ID Numbers: PANAG-001
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018

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

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Capsaicin
Caryophyllene
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents