title: Double-blind, randomized, placebo-controlled study to evaluate the effects of tegaserod on gastric motor, sensory and myoelectric function in healthy volunteers.
abstract: BACKGROUND
  The effects of tegaserod on gastric accommodation and postprandial satiety remain unclear.
  
  
  OBJECTIVE
  To 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.
  
  
  METHODS
  Randomized, 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.
  
  
  RESULTS
  There 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).
  
  
  CONCLUSIONS
  While 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.
authors.affiliation: 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
authors.forename: N J
authors.initials: NJ
authors.lastname: Talley
authors.forename: M
authors.initials: M
authors.lastname: Camilleri
authors.forename: D
authors.initials: D
authors.lastname: Burton
authors.forename: G
authors.initials: G
authors.lastname: Thomforde
authors.forename: K
authors.initials: K
authors.lastname: Koch
authors.forename: M J
authors.initials: MJ
authors.lastname: Rucker
authors.forename: J
authors.initials: J
authors.lastname: Peterson
authors.forename: A R
authors.initials: AR
authors.lastname: Zinsmeister
authors.forename: D L
authors.initials: DL
authors.lastname: Earnest
mesh_terms: D000284:Administration, Oral; D000328:Adult; D019422:Dietary Sucrose / Q000008:administration & dosage; D004311:Double-Blind Method; D004576:Electromyography / Q000379:methods; D005215:Fasting / Q000502:physiology; D005260:Female; D005526:Food, Formulated; D005746:Gastric Emptying / Q000187:drug effects; D005765:Gastrointestinal Agents / Q000008:administration & dosage*; D005772:Gastrointestinal Transit / Q000502:physiology; D006801:Humans; D007211:Indoles / Q000008:administration & dosage*; D007421:Intestine, Small / Q000502:physiology; D008297:Male; D019518:Postprandial Period; D012528:Satiety Response; D017366:Serotonin Receptor Agonists / Q000008:administration & dosage*; D013270:Stomach / Q000187:drug effects* / Q000502:physiology
chemical_list: D019422:Dietary Sucrose; D005765:Gastrointestinal Agents; D007211:Indoles; D017366:Serotonin Receptor Agonists; C082131:Ensure formulated food; C105050:tegaserod