A Randomized, Double-Blind, Placebo-Controlled Trial Using Cannabidiol and Palmitoylethanolamide for the Treatment of Painful Diabetic Peripheral Neuropathy of the Feet
Overview
- Phase
- Phase 1
- Intervention
- CBD/PEA
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Sponsor
- Pure Green Pharmaceuticals Inc.
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Pain as assessed by Numerical Pain Rating Scale (NPRS)
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of the study is to evaluate whether the DIA/NPR-6 is a better pain reliever in patients with diabetic neuropathic pain of the feet compared to placebo.
Detailed Description
Subjects will be enrolled in the study for a maximum of 63 days, including an optional 14-day screening period, 42 days of active product administration, and followed by post-treatment blood work, EKG, and questionnaires within 24-hours following study treatment completion and a psychiatric and primary health care provider evaluation within 1 week of trial completion. The primary objective of this study is: * To evaluate the impact of PGP-010-50-1 on subject's painful diabetic neuropathic pain (pDNP), anxiety, and sleep quality compared to a placebo control. * To evaluate the impact of PGP-010-50-1 on the subject's impression of their response to the treatment compared to a placebo control. The secondary objectives of this study are: * To evaluate the safety of PGP-010-50-1 for the treatment of painful diabetic peripheral neuropathy (DPN) of the feet compared to a placebo control * To evaluate PGP-010-50-1 on liver function. * To evaluate PGP-010-50-1 on Hbg A1C
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is at least 21 years of age.
- •Subject is or under the age of 65 years of age.
- •Subject has a primary health care provider and gives permission for PG Pharma to contact the primary health care provider.
- •Subject has a diagnosis of diabetic neuropathic pain of the feet .
- •Subject has a mean pain scale score of ≥ 4 and ≤ 8 recorded localized to the foot in the 7 days prior to randomization.
- •If female, the subject is postmenopausal (\> 1 year), surgically sterile (\> 3 months), had a hysterectomy, or is currently using 2 effective forms of birth control.
- •Subject has not taken marijuana (cannabis) in any form, chemicals or extracts or foods or beverages or topical creams, lotions, gels, patches containing marijuana (cannabinoids, or and cannabis derivatives) including synthetic marijuana and/or CBD for at least 14 days prior to this study, and agrees to not take marijuana (cannabis) in any form, chemicals or extracts or foods or beverages or topical creams, lotions, gels, patches containing marijuana (cannabinoids, or and cannabis derivatives) including synthetic marijuana and/or CBD while participating in this study.
- •Subject is willing to provide his/her written informed consent to participate in the study as stated in the informed consent document.
- •Subject has a smart phone, knows how to use it, and is willing to use it for accessing and interacting with an electronic diary to enter trial information for the duration of the study - 57 days. (up to 14-day screening period and 42 days active dosing and 1 day post dosing.
Exclusion Criteria
- •Subject is pregnant or lactating.
- •Subject is unwilling to utilize two forms of birth control with partner.
- •Male subject is unwilling to agree to not donate sperm from the time of dosing until 90 days after dosing of study drug.
- •Subject has an allergy to cannabis, the Cannabaceae plant family (e.g., hemp, hops), palmitoylethanolamide, or terpenes.
- •Subject has a known allergy to active or inert ingredients of the investigational product.
- •Subject is taking a concomitant medication or treatment that would complicate use or interpretation of the study drug's effects (examples include: Cannabis or any cannabinoid products; Any drug or herbal product that influences the endocannabinoid system (ECS)). However, subjects are allowed to continue gabapentin and pregabalin medications, if the subject still meets the pain scale inclusion criteria, evidencing lack of effectiveness of their concomitant pain medication.
- •Subjects on SNRIs or SSRIs.
- •Subject is taking marijuana (cannabis) in any form, chemicals or extracts or foods or beverages or topical creams, lotions, gels, patches containing marijuana (cannabinoids, or and cannabis derivatives) including synthetic marijuana and/or CBD for at least 14 days prior to this study, and does not promise that they will not take marijuana (cannabis) in any form, chemicals or extracts or foods or beverages or topical creams, lotions, gels, patches containing marijuana (cannabinoids, or and cannabis derivatives) including synthetic marijuana and/or CBD while participating in this study;
- •Subject has shortness of breath.
- •Subject has uncontrolled asthma.
Arms & Interventions
CBD/PEA
Subject will receive a 42-day supply of 10/50 mg CBD/PEA sublingual tablets to be taken 3 times a day for 42 days.
Intervention: CBD/PEA
Placebo Control
A placebo sublingual tablet to be taken three times a day for 42 days.
Intervention: Placebo
Outcomes
Primary Outcomes
Pain as assessed by Numerical Pain Rating Scale (NPRS)
Time Frame: Six Weeks
To evaluate the impact of DIA/NPR-6 on the subject's neuropathic pain as assessed by utilizing a Numeric Pain Rating Scale (NPRS). NPRS is from 0-10, where higher scores indicate worse pain, and lower scores indicate less pain reported by the subject.
Anxiety as measured by the Self-Rating Anxiety Scale (SAS)
Time Frame: Six Weeks
To evaluate the impact of DIA/NPR-6 on the subject's anxiety as assessed by the Self-Rating Anxiety Scale (SAS). Subjects will complete SAS prior to first dose and during post-treatment.
Pain as measured by the Brief Pain Inventory (BPI)
Time Frame: Six Weeks
To evaluate the impact of DIA/NPR-6 on the subject's neuropathic pain as assessed by utilizing a Brief Pain Inventory (BPI) where patients will answer 15 questions regarding their pain.
Sleep as measured by the Pittsburg Sleep Quality Index (PSQI)
Time Frame: Six Weeks
To evaluate the impact of DIA/NPR-6 on the subject's sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI). Subjects will be evaluated pre- and post-treatment. The PSQI produces a global score and 6 subscales, Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disturbances, Use of Sleeping Medications, and Daytime Dysfunction.
Secondary Outcomes
- Incidence of treatment-related adverse events as assessed by CTCAE v4.0(Six Weeks)
- Subject's Response to Treatment as assessed by Patient's Global Impression of Change (PGIC)(Six Weeks)