Dose-Response Characterization of VER-01 in the Treatment of Patients With Chronic Non-specific Low Back Pain
brief summary
Dose-response characterization of VER-01 in patients with chronic non-specific low back pain (CLBP) for whom drug treatment is indicated and previous optimized treatments with non-opioid analgesics have not led to sufficient pain relief or were unsuitable due to contraindications or intolerance.
detailed description
The primary objective of this multicenter, double-blind, randomized, placebo-controlled trial is to characterize the dose-response relationship of VER-01 in terms of pain reduction in patients with chronic non-specific low back pain.
Eligible patients are randomized to one of four different dose groups (cohorts) in a 1:1:1:1 ratio and either active drug (VER-01) or placebo.
The secondary objectives are to evaluate the efficacy using additional outcome measures, the safety and the tolerability of VER-01 compared to placebo.
official title
Multicenter, Double-blind, Randomized, Placebo-controlled, Dose Response Trial With the Full-spectrum Cannabis Extract VER-01 in Patients With Chronic Non-specific Low Back Pain