ADEQUATE RELIEF AS AN END-POINT IN CLINICAL-TRIALS IN IRRITABLE-BOWEL-SYNDROME

Irritable bowel syndrome is characterized by recurrent abdominal pain and altered bowel function. In designing studies to evaluate new treat ments for this disease, however, it is difficult to select appropriate endpoints to reflect improvement in the range of symptoms of the synd rome. In the present study we evaluated the parameter of adequate reli ef of abdominal pain and discomfort, as perceived by the patients, as a key endpoint for efficacy in the treatment of patients with irritabl e bowel syndrome. Abdominal pain and bowel function data were collecte d daily from 370 patients with the disease during treatment with place bo or a novel potent 5HT(3) receptor antagonist. Once every 7 days ade quate relief of pain and discomfort was assessed. Quality-of-life data were collected using self-administered questionnaires. The endpoint o f adequate relief was significantly (P < 0.05) correlated with improve ment in pain severity scores, percentage of pain-free days, percentage of days with urgency improvement in stool frequency and consistency, and quality-of-life parameters. Adequate relief of pain and discomfort is significantly correlated with changes in multiple parameters assoc iated with irritable bowel syndrome and can be used as an endpoint for assessing response to therapy in these patients.