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

Inclusion Criteria: 1. Patient meets the Quebec Task Force (QTF) classification system of categories 1 to 3 of low back pain 2. Male and female patients ≥ 18 years of age 3. Provision of informed consent form (ICF) voluntarily signed and dated by the patient 4. For female patients of childbearing potential and male patients of reproductive potential: use of a reliable contraceptive method (Pearl index \< 1) at least 1 month before the screening visit and willingness to use it during the trial participation and 3 months after the last intake of the test or comparative intervention 5. Patient understands the local language and is willing and able to comply with scheduled visits, treatment plan, eDiary, and other trial-related procedures throughout trial participation 6. Chronic (≥ 3 months) non-specific pain in the lower back (between the 12th thoracic vertebra and lower gluteal folds). Non-specific pain refers to pain without a clear specific somatic cause, for which targeted therapy can have a positive effect on the course of the disease. Such somatic causes are e.g., herniated vertebral disk, spinal canal stenosis, inflammatory back pain, osteoporosis, fracture, infection, tumor, spondylolisthesis 7. Patients with indicated opioid drug treatment\* where previous optimized treatments\*\* with non-opioid analgesics (including combinations) have not led to sufficient pain relief or were unsuitable due to contraindications or intolerance 8. Low back pain intensity on average ≥ 4 points on an 11-point NRS in the last 4 weeks prior Visit 1 9. In case of non-drug therapy in the 4 weeks prior to Visit 1 (e.g., exercise or behavioral therapy, acupuncture, massage, thermotherapy) that significantly modulates pain perception: the non-drug therapy was unchanged and is still ongoing at Visit 1 and all requirements for continuation of the therapy throughout the trial are given (e.g., prescription, patient's compliance). Ongoing non-drug therapies should be continued unchanged during trial participation 10. Willingness to not take or use any prohibited medication during trial participation. The intake or use of any additional analgesic medication (non-opioid and opioid analgesics as well as adjuvant analgesics and muscle relaxants), during trial participation is prohibited (except rescue medication). Likewise, strong inhibitors, substrates, or inducers of CYP2C9 and CYP3A4 are considered prohibited concomitant medication in this trial Exclusion Criteria: 1. Patients wit…