Double-blind, randomized, placebo-controlled study to evaluate the effects of tegaserod on gastric motor, sensory and myoelectric function in healthy volunteers.
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.
Talley
N J
NJ
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
Camilleri
M
M
Burton
D
D
Thomforde
G
G
Koch
K
K
Rucker
M J
MJ
Peterson
J
J
Zinsmeister
A R
AR
Earnest
D L
DL
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
D019422:Dietary Sucrose; D005765:Gastrointestinal Agents; D007211:Indoles; D017366:Serotonin Receptor Agonists; C082131:Ensure formulated food; C105050:tegaserod