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Authors
Meissner, Winfried
Argoff, Charles
Sator, Sabine
Schoder, Volker
Karst, Matthias https://orcid.org/0000-0002-3502-0023
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Clinical Trials BETA
Clinical trials referenced in this document:
nct05610813 at ClinicalTrials.govDocuments that mention this clinical trial
VER-01 Shows Enhanced Gastrointestinal Tolerability, Superior Pain Relief, and Improved Sleep Quality Compared to Opioids in Treating Chronic Low Back Pain: A Randomized Phase 3 Clinical Trial
https://doi.org/10.1007/s40122-025-00773-z
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Funding
Funding for this research was provided by:
Vertanical GmbH
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Article History
Received: 16 June 2025
Accepted: 29 August 2025
First Online: 30 September 2025
Declarations
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: Winfried Meissner has received payments for advisory boards and talks from Sanofi, MSD, Tafalgie, Kyowa, Mundipharma, Grünenthal, and Ethypharm. His institution has received research support from the European Commission, Gemeinsamer Bundesausschuß (GBA), Medtronic, Pfizer, Mundipharma, Grünenthal, and Vertanical. Charles Argoff has received consultancy fees from Vertanical. Sabine Sator has received payments for speaker honoraria, advisory boards, and consensus from Grünenthal Austria, Medtronic, Ratiopharm Austria, and Novartis Austria. At the time of the study, Volker Schoder was employed by Metronomia, which was contracted to perform statistical analysis. Matthias Karst has received speaker honoraria from the Federal Association of Pharmaceutical Cannabinoid Companies (BPC), Cannabis Social Club Bolzano, Cannamedical, Demecan, Grunenthal, Hormosan, Meet Your Master, Medical Service of the Health Insurance Funds, Novartis, Stadapharm, and Tilray; consultancy fees from Tetra Pharm and Vertanical; and expert opinion fees from several local and social organizations. His institution has received research support from the Friedrich and Alida Gehrke-Foundation, German Pension Insurance Braunschweig-Hannover, Lower Saxony Ministry for Science and Culture, and Vayamed.
: The trial was conducted at 41 outpatient sites and hospitals across Europe (Germany, Czech Republic, Poland, Spain) in compliance with the principles of the Declaration of Helsinki, the Good Clinical Practice guidelines of the International Council for Harmonization, and applicable regulatory requirements. Approval was obtained from all relevant Ethics Committees in each participating country. A comprehensive list of independent Ethics Committees involved—classified as central or local—is provided in ESM Table . Written informed consent, including consent for publication of anonymized trial results, was obtained from all patients prior to enrollment.
