• Aliment. Pharmacol. Ther. · Sep 2006

    Randomized Controlled Trial

    Double-blind, randomized, placebo-controlled study to evaluate the effects of tegaserod on gastric motor, sensory and myoelectric function in healthy volunteers.

    • N J Talley, M Camilleri, D Burton, G Thomforde, K Koch, M J Rucker, J Peterson, A R Zinsmeister, and D L Earnest.
    • Translational & Epidemiological Research Program, Mayo Clinic Division of Gastroenterology and Hepatology, and Clinical Enteric Neuroscience, Mayo Clinic College of Medicine, Rochester, MN 55905, USA. talley.nicholas@mayo.edu
    • Aliment. Pharmacol. Ther. 2006 Sep 1;24(5):859-67.

    BackgroundThe effects of tegaserod on gastric accommodation and postprandial satiety remain unclear.AimTo compare the effects of tegaserod 6 mg twice daily vs. placebo on gastric volumes, postprandial symptoms, gastric emptying, small bowel transit and the surface electrogastrogram in female and male healthy volunteers.MethodsRandomized, double-blind, placebo-controlled study evaluated gastric function before and after 7 days of tegaserod 6 mg twice daily (n = 21) vs. placebo (n = 20) in healthy volunteers. Validated methods were used to study gastric emptying, myoelectrical activity, volumes and satiation postnutrient challenge.ResultsThere were no significant effects of tegaserod on the primary endpoints assessing gastric function: emptying of solids or liquids, total gastric volumes or myoelectrical activity. Maximum tolerated volume and aggregate symptom score with nutrient challenge on placebo were 1,035 mL (+/-44) and 130 (+/-15) vs. 989 mL (+/-43) and 117 (+/-15) during tegaserod, respectively (all P = N.S.). Postprandial change in proximal gastric volume by single photon emission-computed tomography was decreased in females on tegaserod (246 +/- 30) vs. placebo (358 +/- 32) (P = 0.015). Proximal fasting volumes in females were increased on tegaserod (126 +/- 12) vs. placebo (92 +/- 13) (P = 0.066).ConclusionsWhile tegaserod decreased proximal gastric volume change after a meal, it does not appear to have significant effects on gastric motor and sensory function in healthy individuals. Further studies are required in patients with disturbances of gastric motor and sensory function.

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