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Efficacy and Safety of VER-01 in the Treatment of Patients With Chronic Non-specific Low Back Pain

NCT04940741 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 820

Last updated 2024-04-08

No results posted yet for this study

Summary

Analysis of the efficacy, maintenance of efficacy, long-term safety, and investigation of the potential for dependence and abuse and the effect of abrupt drug withdrawal of VER-01 in the treatment of patients with chronic non-specific low back pain when drug treatment is indicated and previous optimised 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

standardised cannabis extract (containing 21 mg THC per gram drug product)

OTHER

Placebo

comparator without active ingredient

Sponsors & Collaborators

  • Vertanical GmbH

    lead INDUSTRY

Principal Investigators

  • Joachim Nadstawek, Prof. · Schmerzzentrum Bonn

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-07
Primary Completion
2024-03-26
Completion
2024-03-26

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 NCT04940741 on ClinicalTrials.gov