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Comparison of VER-01 to Opioids in Patients With Chronic Non-specific Low Back Pain — ELEVATE  

Chronic Non-specific Low Back Pain Clinical Trial

Official title:
Multicentre, Randomized, Open-label Study to Prove an Additional Benefit of the Full-spectrum Cannabis Extract VER-01 Over Opioids in the Treatment of Patients With Chronic Non-specific Low Back Pain

Clinical Trial Summary

Randomized, open-label, parallel-group phase III trial to prove an additional benefit of the full-spectrum cannabis extract VER-01 over opioids in patients with chronic non-specific low back pain 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.

Clinical Trial Description

The test intervention VER-01 is a cannabis-based pain medication currently under clinical development that is expected to provide adequate pain relief while being better tolerated in long-term treatment compared to opioid analgesics. This study aims to demonstrate the superior tolerability, especially in terms of bowel function, of VER-01 compared to existing authorised and marketed opioid analgesics in patients with chronic non-specific low back pain. In addition, the safety and tolerability as well as the efficacy of VER-01 compared to opioid therapy will be evaluated. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05610813
Study type Interventional
Source Vertanical GmbH
Contact
Status Active, not recruiting
Phase Phase 3
Start date June 8, 2023
Completion date December 2024
View Details
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