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Racecadotril is a chemically synthesised substance that is taken by mouth. It is already authorised as a medicine in some countries and is best known as a treatment for acute diarrhoea. In the EU Clinical Trials Information System, the substance appears under the name RACECADOTRIL and is recorded as an auxiliary medicine in one trial.[1]
Racecadotril acts in the intestine to reduce the secretion of water and salts into the bowel. This helps to reduce the amount of fluid lost in diarrhoea. The mechanism is described in product information for racecadotril-containing medicines.[2]
Racecadotril is given by mouth. In the trial record, the product is listed as RACECADOTRIL 200 mg for oral use.[1] The route of administration for the substance is oral.[1]
One EU trial record includes racecadotril. The trial is a randomised, double-blind, controlled Phase 3 study that planned to enrol 134 participants with severe recurrent aphthous stomatitis resistant or intolerant to colchicine.[1] The study compares apremilast against placebo. Racecadotril is not the main medicine being tested; it is recorded as an auxiliary medicine, meaning it is used in a supporting role.[1]
The trial is currently suspended, so no results are available from this record.[1] The primary endpoint is sustained complete response, defined as having no oral ulcer at the Week 12, Week 14 and Week 16 evaluations.[1]
According to a European Medicines Agency document, serious skin reactions have been reported with racecadotril. These include drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal. Anaphylactic shock has also been reported.[2]
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