Effect of renzapride on transit in constipation-predominant irritable bowel syndrome Michael Camilleri, Sanna McKinzie, Jean Fox, Amy Foxx-orenstein,

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Effect of renzapride on transit in constipation-predominant irritable bowel syndrome Michael Camilleri, Sanna McKinzie, Jean Fox, Amy Foxx-orenstein, Duane Burton, George Thomforde, Kari Baxter, Alan R. Zinsmeister Clinical Gastroenterology and Hepatology Volume 2, Issue 10, Pages 895-904 (October 2004) DOI: 10.1016/S1542-3565(04)00391-X Copyright © 2004 American Gastroenterological Association Terms and Conditions

Figure 1 Trial flow. Clinical Gastroenterology and Hepatology 2004 2, 895-904DOI: (10.1016/S1542-3565(04)00391-X) Copyright © 2004 American Gastroenterological Association Terms and Conditions

Figure 2 (A) The effect of renzapride on colonic transit summaries. Note that the dose-related effects of renzapride on colonic transit are shown most clearly in the GC8- and GC24-hour data. (B) These 2 sets of scintigraphic images were obtained from 2 different study patients—1 on placebo (top panel), and 1 on renzapride 4 mg (bottom panel). The left images are after 8 hours, and the right images are the 24-hour images for each individual. As these images show, renzapride accelerates movement of the radioisotope through the colon both at 8 and 24 hours, when compared with placebo. Clinical Gastroenterology and Hepatology 2004 2, 895-904DOI: (10.1016/S1542-3565(04)00391-X) Copyright © 2004 American Gastroenterological Association Terms and Conditions

Figure 3 AC emptying t1/2 shown as the probability to empty 50% of the isotope in the defined time. Note that the 4-mg dose significantly accelerated AC emptying relative to placebo (P < 0.05), and the median t1/2 was shortened substantially by renzapride, particularly the 4-mg dose. Clinical Gastroenterology and Hepatology 2004 2, 895-904DOI: (10.1016/S1542-3565(04)00391-X) Copyright © 2004 American Gastroenterological Association Terms and Conditions

Figure 4 Stool frequency, (A) stool form, and (B) ease of passage in response to renzapride or placebo. Note the greater consistency (implying looser stools on average) and greater ease of passage with renzapride treatment. Clinical Gastroenterology and Hepatology 2004 2, 895-904DOI: (10.1016/S1542-3565(04)00391-X) Copyright © 2004 American Gastroenterological Association Terms and Conditions

Figure 5 Relationship between stool form or ease of stool passage and colonic transit estimated by the colonic GC24 hours (upper panels) and GC48 hours (lower panels). Clinical Gastroenterology and Hepatology 2004 2, 895-904DOI: (10.1016/S1542-3565(04)00391-X) Copyright © 2004 American Gastroenterological Association Terms and Conditions

Figure 6 Plot of change in colonic transit (GC24h) and peak systemic drug levels in response to renzapride. The filled symbols identify patients who reported satisfactory relief of IBS symptoms at week 2 (all dose groups). Data are not plotted for 5 patients. (In the 1-mg group, 1 patient had no pharmacokinetic data; in the 2-mg group, 1 patient did not answer the weekly relief question, and 1 nonresponder had no PK data; in the 4-mg group, 2 patients did not answer the relief question in week 2.)◊;, 1 mg; □, 2 mg; ▵, 4 mg. ◊, ■, ▴, denoted responders for relief of IBS symptoms at week 2. Clinical Gastroenterology and Hepatology 2004 2, 895-904DOI: (10.1016/S1542-3565(04)00391-X) Copyright © 2004 American Gastroenterological Association Terms and Conditions