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

PHASE3CompletedINTERVENTIONAL
Enrollment

384

Participants

Timeline

Start Date

June 8, 2023

Primary Completion Date

October 18, 2024

Study Completion Date

October 18, 2024

Conditions
Chronic Non-specific Low Back Pain
Interventions
DRUG

VER-01

Standardized oleoresin of Cannabis sativa L. folium cum flore, THC-chemotype (cannabis leaves and - flowers), corresponding to 21 mg (-)-trans-Δ9-Tetra-hydrocannabinol (THC) per gram drug product

DRUG

Opioid therapy

The patient-specific selection of the marketed opioid (based on standard of care and provided for this study) is at the discretion of the investigator and made at Visit 1, i.e., before randomization at Visit 2.

Trial Locations (2)

18209

Rheumazentrum Prof. Dr. med. Gunther Neeck, Bad Doberan

30625

Medizinische Hochschule Hannover (MHH), Hanover

All Listed Sponsors
lead

Vertanical GmbH

INDUSTRY

NCT05610813 - Comparison of VER-01 to Opioids in Patients With Chronic Non-specific Low Back Pain | Biotech Hunter | Biotech Hunter