FDA Issues Clinical Development Guidance for Gastroparesis Drugs
The FDA names five acceptable endpoints for trials of gastroparesis treatments in a new draft guidance.
The agency says that five core signs and symptoms of the disease that prevents proper emptying of the stomach should be used as primary endpoints: nausea, vomiting, fullness after a meal, early satiety and abdominal pain.
Sponsors should provide a primary endpoint definition and a method for measuring each of the five signs and symptoms described in the guidance. For example, the agency recommends that all signs be given a rating of severity, except for vomiting, which should be measured in terms of the number of times it occurs over a 24-hour period.