Chronic non-specific low back pain
Conditions
Sponsors
Vertanical GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients =18 years of age 2. Provision of informed consent form voluntarily signed and dated by the patient 3. For women of childbearing potential and men of reproductive potential: use of a reliable contraceptive method (Pearl index =65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
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 obstructio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To prove a reduced risk of developing constipation under treatment with VER-01 compared to an opioid therapy at the end of treatment phase (visit 9);Secondary Objective: Further evaluate the safety and tolerability of VER-01 compared to an opioid therapy Compare efficacy of VER-01 to an opioid therapy;Primary end point(s): Number and proportion of constipation responders at the end of treatment phase (visit 9). A constipation responder is defined as a patient with 1. a change from baseline (visit 2) in Bowel Function Index (BFI) total score of at least 15 points at visit 9 and 2. a BFI total score of more than 28.8 at visit 9.;Timepoint(s) of evaluation of this end point: visit 9 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Number and percentage of 30% pain responders at study week 27 (last week of treatment phase) compared with the baseline score (study week -1) 2. Number and percentage of 30% pain responders in the subgroup of patients with a neuropathic pain component (painDETECT score > 18) at study week 27 compared with the baseline score (study week -1) 3. Number and percentage of patients with a 30% improvement of the mean daily low back pain interference with sleep score evaluated on an 11-point Numeric Rating Scale (NRS) at study week 27 compared with the baseline score (study week -1);Timepoint(s) of evaluation of this end point: Week 27 | — |
Countries
Czechia, Germany, Poland, Spain
Contacts
Public ContactTobias Gruber
Vertanical GmbH
Outcome results
None listed