Topical Use of 20% Beta Caryophyllene Alone And In Combin... | NCT03152578

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2017Actual

Primary Completion Date

Jun 30, 2019Actual

Completion Date

Jul 31, 2019Actual

First Submitted Date

May 11, 2017

First Submission Date that Met QC Criteria

May 11, 2017

First Posted Date

May 15, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 2, 2020

Last Update Posted Date

Jan 6, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BetaC + Capsacian	Active Comparator	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 Only	Active Comparator	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
Placebo	Placebo Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BetaC + Capsaicin Topical Cream	Other	BetaC + Capsacin Topical Cream applied to painful knee area 3 times per day.	BetaC + Capsacian

Measure	Description	Time Frame
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

Measure	Description	Time Frame
BPI-Short Form		12 weeks
Patient's Global Impression of Change		12 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms