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Dose-Response Characterization of VER-01 in the Treatment of Patients With Chronic Non-specific Low Back Pain

NCT06475001 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 652

Last updated 2025-08-11

No results posted yet for this study

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.

Conditions

  • Chronic Non-specific Low Back Pain

Interventions

DRUG

VER-01

Herbal medicinal product, containing as active substance a soft extract of Cannabis sativa L., cannabis flos (Cannabis flower), adjusted to a content of 50 mg/g delta-9-tetrahydrocannabinol (THC). VER-01 is adjusted to a concentration of 19 mg/mL THC by adding the excipient sesame oil.

DRUG

Placebo

Comparator without active ingredient

Sponsors & Collaborators

  • Vertanical GmbH

    lead INDUSTRY

Principal Investigators

  • Martin Johnson, Dr. · St Pancras Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-28
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT06475001 on ClinicalTrials.gov