A Study of Medical Cannabis Aerosol Via the Fixed-dose Syqe Inhaler as an Add-on Treatment of Dia⦠(NCT06490445) | Clinical Trial Compass
Active β Not RecruitingPhase 2
A Study of Medical Cannabis Aerosol Via the Fixed-dose Syqe Inhaler as an Add-on Treatment of Diabetic Peripheral Neuropathic Pain (DPNP)
Australia122 participantsStarted 2024-11-14
Plain-language summary
The primary purpose of this study is to evaluate the safety and efficacy of medical cannabis aerosol containing 0.25, 0.50, 1.0 milligrams (mg) delta (Ξ) 9-tetrahydrocannabinol (THC) inhaled three times a day (TID) compared to placebo via the Fixed-dose Syqe Inhaler on pain intensity at Week 15.
Who can participate
Age range18 Years β 75 Years
SexALL
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Inclusion criteria
β. Able to comprehend and willing to sign the informed consent form (ICF), and willing to abide by the study restrictions.
β. Males and females aged between 18 (included) and 75 (included) years.
β. Agree to use only medical cannabis provided by study team until the end of study (EOS) and not to use any other cannabis or cannabis-containing products.
β. Agree not to participate in other interventional clinical studies during participation in this study.
β. Treated with standard of care for DPNP, defined as either duloxetine, gabapentin or pregabalin as monotherapy or a combination of 2, or participants who discontinued the use of standard of care, or amitriptyline used for the management of pain related to DPNP, at least 3 months prior to screening.
β. Confirmed diagnosis of diabetes mellitus type I or type II with stable disease.
β. Glycated hemoglobin (HbA1c) less than or equal to (\<=) 10% at screening.
β. Body mass index between 18 and 40 kilograms per square meter (kg/m\^2), inclusive.
Exclusion criteria
β. Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol at screening or randomization, ability to complete the study, or study assessments.
β. Presence of skin conditions in the affected dermatome at screening or randomization that could interfere with the evaluation of the neuropathic pain condition.
What they're measuring
1
Change From Baseline in Weekly-mean 24-hour Average Pain Score on the Numeric Rating Scale (NRS) at Week 15
β. Presence of pain not associated with diabetic peripheral neuropathy (DPN) or other neuropathies that may interfere with study assessments.
β. Known history of significant hypersensitivity, intolerance, adverse reaction or allergy to cannabis products, cannabinoids, or acetaminophen/paracetamol.
β. Malignancies in the past 5 years prior to screening, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
β. Liver disease or liver injury as indicated by abnormal liver function tests at screening.
β. History or presence of impaired renal function at screening
β. Presence of significant pulmonary disease at screening