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

NCT05610813 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2024-11-25

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Vertanical GmbH

    lead INDUSTRY

Principal Investigators

  • Matthias Karst, Prof.Dr.med. · Medizinische Hochschule Hannover (MHH)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-08
Primary Completion
2024-10-18
Completion
2024-10-18

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05610813 on ClinicalTrials.gov