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

Exclusion Criteria

• •1. Patients with a known history of alcohol/drug/medication abuse or dependency and previous or current use of methadone
• •2. Evidence of drugs of abuse or illegal drugs by urine drug test performed at visit 1
• •3. Known intolerance or hypersensitivity to ingredients of rescue medication, opioid therapy (assigned by the investigator) and/or VER-01
• •4. Participation in another clinical interventional study within the last 30 days prior screening visit (visit 1)
• •5. Occupational groups with primary activity of operating machinery and driving motor vehicles
• •6. Planned blood donation or planned donation or freezing of sperm or oocytes during study participation and 3 months after end of study participation
• •7. Pregnant or breastfeeding female patients
• •8. Patient is unable to provide written informed consent, in need for care, has a guardian/caretaker, is immobile, or is particularly vulnerable (e.g., imprisoned; institutionalised by a court or judicial authority; dependent or employed by the sponsor, an external service provider of the sponsor (involved in the conduct of the study), the investigator or the trial site)
• •9. Known use of opioid or cannabis-based treatments within 30 days before screening visit (visit 1)
• •10. Patients for whom cannabis or opioid therapy is not indicated, e.g., due to a history of non-response to opioid therapy or cannabis-based medicines in the treatment of chronic non-specific low back pain in the past.
• •11. Start of or planned non-drug pain therapy during run-in phase (physical or behavioral therapy)
• •12. Start or planned start of an additional analgesic treatment during run-in phase
• •13. Ongoing monoamine oxidase inhibitor therapy at screening visit (visit 1)
• •14. Patients with history of cancer in the last 5 years prior to screening visit (visit 1). Except for cutaneous basal cell or squamous cell cancer resolved by excision without recurrence and cervical cancer in situ resolved by excision with negative pap test.
• •15. Painful comorbidities which could interfere with the low back pain intensity assessment during the study
• •16. Known history of human immunodeficiency virus (HIV) infection
• •17. Severe forms of the following diseases: Anaemia, haematological / autoimmune / endocrine / renal / hepatic / respiratory / cardiovascular / neurological / gastrointestinal / symptomatic peripheral vascular diseases.
• •18. Cardiovascular event in the last three months before screening visit (visit 1)
• •19. Known uncontrolled hypertension (average systolic blood pressure ≥140 mmHg or average diastolic blood pressure
• •≥90 mmHg) and/or untreated hypothyroidism
• •20. Patients with Crigler-Najjar syndrome, Rotor syndrome and/or porphyria
• •21. History of major trauma or back surgery in the last 2 months prior to screening visit (visit 1)
• •22. Known history of or current severe psychiatric illness
• •23. Known history of or current severe depression (not due to chronic low back pain) (assessed by Patient Health Questionnaire - 9) and/or suicidal ideation (assessed by Columbia-Suicide Severity Rating Scale) at screening visit (visit 1)
• •24. Patients with severe respiratory depression
• •25. Patients with lung disease associated with impaired lung function (e.g., acute or severe bronchial asthma or hypercapnia/respiratory failure).
• •26. Patients with conditions of increased intracranial pressure due to head injury or disease of the brain.
• •27. Patients with existing or suspected paralytic ileus
• •28. Patients with intestinal obstruction due to intestinal paralysis