UnknownPhase 2

Using Cannabidiol to Treat Diabetic Peripheral Neuropathy of the Feet

United States50 participantsStarted 2020-12-10

Plain-language summary

The purpose of the study is to evaluate whether PG-DN-20WS is a better pain reliever in patients with diabetic neuropathic pain of the feet than a placebo.

Who can participate

Age range21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subject is at least 21 years of age;
✓. Subject has a diagnosis of diabetic neuropathic pain of the feet determined by the subject's primary care physician or related health care provider.
✓. Subject has a mean pain scale score of ≥ 5 recorded 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.
✓. If subject is currently taking gabapentin, pregabalin, or duloxetine, subject must be willing to and completes a 7-day washout of these medications prior to randomization.
✓. Subject has not taken any NSAIDs and/or acetaminophen for at least 2 days prior to randomization.
✓. Subject is willing to provide his/her written informed consent to participate in the study as stated in the informed consent document.

Exclusion criteria

✕. Subject is pregnant or lactating;
✕. 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));
✕. 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 currently resides in the state of Nebraska, Idaho, Iowa, or South Dakota.
✕. Subject is currently being treated with antibiotics for sinus, throat, or lung infections;
✕. Subject has shortness of breath associated with allergies;

What they're measuring

Incidence of treatment-related adverse events as assessed by CTCAE v4.0

Timeframe: Four Weeks

Trial details

NCT IDNCT04679545

SponsorPure Green

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-03-01

Contact for this trial

Matthew Caloura

(248) 802-4380 mcaloura@pgpharma.co

View on ClinicalTrials.gov More Diabetic Peripheral Neuropathic Pain trials