Gastroparesis

  • Testing of the validity of gastroparesis symptom questions
  • Sub group analysis of gastroparesis patients interviewed in exploratory phase, Rasch analysis and PCA on a 5 item scale
  • Phase III statistical analysis plan and regulatory consulting on the gastroparesis symptom assessment (GSA) for submission
  • Review of a protocol amendment for a phase II gastroparesis study which includes the Care-giver Strain Index (CGSI) as a primary endpoint
  • Review of protocol on a phase II study of subjects with severe gastroparesis due to diabetes mellitus
  • Cognitive debriefing of a symptom measure of gastroparesis in diabetics and standalone validation study