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.
The study is divided into four phases: Phase A, B, C and D. All patients who have completed
Phase A and for whom the investigator considers further participation to be safe shall begin
Phase B. Phases C and D run in parallel, so that patients who have completed Phase B and for
whom the investigator considers further participation to be safe can be assigned to one of
the two phases.
Phases A and D follow a double-blind, placebo-controlled design, while Phase B and C have an
The main goal of Phase A is to demonstrate the efficacy of VER-01 compared to placebo. In
Phase B and C the main goal is the investigation of long-term safety of VER-01. In Phase D
the primary objective is to demonstrate the maintenance of efficacy of VER-01 on a
The potential for dependence and abuse will be analyzed in all Phases (A,B,C,D), while the
effect of abrupt drug withdrawal of VER-01 will be analyzed in Phase C and D.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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