Functional dyspepsia is defined by the absence of any organ, systemic, or metabolic disease likely to explain symptoms thought to originate in the gastroduodenal region. It is estimated that up to 40% of the general population experience this condition, however estimates range from 3% to 40%, which reflects the variability in diagnostic criteria used in clinical studies. The Functional Dyspepsia Working Group is developing a PRO measure (i.e., Functional Dyspepsia Symptom Diary [FDSD]) to assess symptoms related to the two functional dyspepsia subtypes: Postprandial Distress Syndrome (PDS) and Epigastric Pain Syndrome (EPS). The FDSD will be used tin clinical trials to assess therapeutic relief of patient symptoms and to support labeling claims.
Working Group Sponsors
Ironwood Pharmaceuticals, Inc.