Clinical field study to evaluate the safety and effectiveness of Canalevia to treat chemotherapy-induced diarrheal in dogs

7. Project Summary/Abstract Chemotherapy-induced diarrhea in dogs (CID) continues to be a common adverse drug event experienced by many dogs undergoing chemotherapy treatment. CID is an even greater threat today with the advent of the newer target agents that effectively kill the cancer but can cause the dog to suffer from severe enough diarrhea to be dehydrating and life-threatening and may require reduction or discontinuation of the use of the targeted therapy. The long-term objective of this research is to design and develop a clinical field study that will demonstrate substantial evidence of effectiveness of Canalevia®-CA1 in the treatment of chemotherapy-induced diarrhea (CID) in dogs. A successful field study is the final step to acquiring full approval of Canalevia from CVM, which will ensure that this product will remain on the market to combat CID in dogs. A total of 240 dogs with a history of CID will be recruited to join the study by their veterinary oncologist during their next regularly scheduled chemotherapy visit. Dog owners will be trained on the use of the Purina Fecal Scoring (PFS) system and on the use of the IWRS cloud-based data capture system that they will download to their mobile telephone or tablet. After returning home, if their dog develops CID, the dog owner will begin twice daily dosing with masked study medication for 3 days, and also begin recording all PFS fecal scores using the IWRS system. Biological samples will be collected at the time of enrollment and again at study end to assess clinical pathology parameters for safety. The expected outcome of this study is a statistical as well as a clinical significance in the superiority of Canalevia to successfully treat CID in dogs vs. placebo, which would allow us to submit the NADA to CVM for full approval of Canalevia to treat CID in dogs. There is no other product on the market that is approved to treat CID in dogs, so gaining full approval of Canalevia through a successful clinical study will ensure that Canalevia remains on the market to be available for the treatment of CID in dogs.