VER-CLBP-001
Research type
Research Study
Full title
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 multicentre study in the treatment of patients with chronic non-specific low back pain.
IRAS ID
282758
Contact name
Michael Graham Serpell
Contact email
Sponsor organisation
Vertanical GmbH
Eudract number
2020-000107-36
Duration of Study in the UK
1 years, 9 months, 31 days
Research summary
Low back pain is one of the most common health problems. In about 90% of low back pain patients it is impossible to find the exact cause of the pain, a condition called non-specific low back pain. If the pain lasts longer than 3 months, it is considered chronic. In this clinical study a novel medicinal product based on an herbal extract for treatment of chronic non-specific low back pain is being investigated.Comparable herbal extracts have been on the market for several years and tested both in clinical studies as well as in everyday clinical practice. This study aims to evaluate the pain relief and long-term safety of this novel medicinal product compared to a placebo to provide a new therapy in the future for patients with chronic non-specific low back pain. A placebo is a product that looks, smells, and tastes like the medicinal product, but contains no active substance. If the medicinal product is well tolerated and it proves to be effective, study participation can last a maximum of 17 months.Participating is possible if the patient has experienced pain in the lower back for more than 3 months with unknown medical cause, is at least 18 years old, has no serious physical or severe psychiatric diseases and is not pregnant, not breast-feeding, and does not actively wish for a child.The study is being conducted at various hospitals and medical practices across Europe.\n\n\n\n\n\n\n
REC name
South Central - Oxford B Research Ethics Committee
REC reference
20/SC/0233
Date of REC Opinion
12 Nov 2020
REC opinion
Further Information Favourable Opinion