Home » FDA Issues Clinical Development Guidance for Gastroparesis Drugs
FDA Issues Clinical Development Guidance for Gastroparesis Drugs
August 19, 2019
The FDA names five acceptable endpoints for trials of gastroparesis treatments in a new draft guidance.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.
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