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Clinical Trials/EUCTR2020-000107-36-AT
EUCTR2020-000107-36-AT
Active, not recruiting
Phase 1

Proof of 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 a multicenter study in the treatment of patients with chronic non-specific low back pain

Vertanical GmbH0 sites808 target enrollmentJanuary 13, 2021
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ConditionsFor 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.Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
For 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.
Sponsor
Vertanical GmbH
Enrollment
808
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 13, 2021
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Male and female patients (18 years and older)
  • •2\. Chronic (for at least three months) non\-specific pain in the lower back (between the lower ribcage and the gluteal folds)
  • •3\. Pain intensity on average at least 4 points on an 11\-point NRS (one month before the start of the study)
  • •4\. Patients with indicated drug treatment\* where previous optimised treatments\*\* with non\-opioid analgesics have not led to sufficient pain relief or
  • •were unsuitable due to contraindications or intolerance.
  • •\* Drug treatment is indicated if analgesic drug therapy is considered supportive for the realisation of activating measures, or if the patient has
  • •unbearable functional disabilities as a result of the pain, despite regularly performing these measures.
  • •\*\* Treatment is considered optimised when
  • •I. a further increased drug dose is unsuitable from a medical perspective considering side effects and/or
  • •II. it is not expected that a higher drug dose would result in a further advantage in terms of efficacy.

Exclusion Criteria

  • •1\. Professional groups for which the ability to operate machinery and drive vehicles is the primary activity (including truck, bus and forklift drivers,
  • •2\. Alcohol/drug/medication abuse and previous or current intake of methadone in the patient's medical history or suspected by the investigator
  • •3\. Intake of analgesic medication (non\-opioid and opioid analgesics as well as adjuvant analgesics) within seven days prior to the start of the study
  • •4\. Taking cannabis\-based medicinal products within 30 days prior to the start of the study
  • •5\. HIV, dementia (which impairs the assessment of symptoms)
  • •6\. Severe forms of the following diseases: Anaemia, hematological/autoimmune/endocrinal/renal/hepatic/respiratory/cardiovascular or
  • •gastrointestinal diseases, symptomatic peripheral vascular diseases
  • •7\. Cardiovascular event in the past three months, poorly managed high blood pressure, untreated hypothyroidism, patients with Crigler\-Najjar
  • •syndrome or Rotor syndrome, surgery within the past two months
  • •8\. Severe mental illnesses (e.g., psychosis, schizophrenia, bipolar disorder) currently or in the past, severe depression not due to chronic low back pain

Outcomes

Primary Outcomes

Not specified

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