Axim Biotech, a world leader in cannabinoid research and development, today announced enrollment of 40 patients and commencement of its Phase II clinical trial for the treatment of irritable bowel syndrome (IBS) with the company’s CanChew Plus® CBD gum. The study is being conducted by Renger Witkamp, Professor and Chair in Nutrition and Pharmacology, at Wageningen University in the Netherlands.
Selected from a pool of over 400 patients, 40 trial patients aged 18-65 will be subject to a randomized, double-blind, cross-over trial of 8 weeks. Patients will receive a maximum 6 chewing gums per day, either containing 50 mg of cannabidiol per chewing gum in case of the CanChew chewing gum, or a placebo chewing gum.
Final data collection for primary outcome measure is estimated to complete in April 2017, with the full study estimated to complete in June 2017.
“We are pleased to have enrolled all patients needed and are fully ready to move ahead with the IBS clinical trial,” said George E. Anastassov, MD, DDS, MBA and Chief Executive Officer of AXIM Biotech. “CanChew Plus is underway to be the first cannabinoid treatments with pharmaceutical application for the IBS indication, and we anticipate further trials with our pharmaceutical grade chewing gum products to treat indications such as inflammatory bowel disease (ulcerative colitis and Crohn’s disease).”
IBS is the most common functional gastrointestinal disorder with a prevalence worldwide ranging from 9-23%. Complaints include abdominal discomfort or pain and altered bowel habits. Although the condition is not life-threatening, it strongly impairs quality of life and up to now there is no cure for IBS. The objective of the study is to investigate whether the use of a CBD-containing CanChew chewing gum can contribute to a reduction of IBS symptoms and an improvement of perceived patients wellbeing.
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