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CSU Animal Cancer Center Clinical Trial

Patient Disease:
Multiple Tumor Types

Study Name:
Clinical Proof of Concept Study to Evaluate the Safety and Effectiveness of Crofelemer (SP-303) for the Treatment of Palladia Chemotherapy-induced Diarrhea in Dogs

Purpose of the study:

  • To provide pilot data of the effectiveness of crofelemer for the treatment of Palladia chemotherapy induced diarrhea (vs. a placebo)
  • Crofelemer has been shown, in preliminary studies, to be effective in relieving acute diarrhea

Primary Eligibility Criteria:

  • Dogs treated with Palladia chemotherapy, that develop diarrhea that is mild to moderate
  • Dogs must be healthy otherwise and be able to continue the Palladia treatments
  • Other medications to control diarrhea are not allowed

Study Protocol:

  • Pre-enrollment: Physical exam, lab testing, veterinarian assigns grade to diarrhea, document current medications
  • Day 0: start treatment with crofelemer  or a placebo (on a schedule), owner takes photos of every bowel movement and uploads into the system (instructions given)
  • Daily phone call to owner for 4 days
  • Study ends: Physical exam, lab work, assign grade to diarrhea, review information with owner

Owner Responsibilities:

  • To make and keep all study related appointments and be in contact with the clinical trials team with updates
  • Continue to administer Palladia to your dog
  • Administer crofelemer per the study schedule
  • Take photos of your dog’s diarrhea and upload them per the study protocol

Financial Incentives:

  • Study drug and all study-related assessments and laboratory analysis with be provided at no cost to the owner
  • One month of Palladia will be provided at no cost to the owner, following the study

If you have further questions about any of our clinical trials, Please either login or sign up to submit a consulting form. Your consult will then be directed to an appropriate oncology clinician. Requests are typically returned within 5 business days