Naproxen-associated gastroduodenal toxicity: enteric coated granules versus plain tablets.
Two naproxen formulations were compared with regard to gastroduodenal endoscopic findings. Using a dose of 500 mg bid for one week, plain tablets were compared to enteric coated granules in a gelatine capsule in a randomized, cross over, double-blind, double dummy study in 16 healthy, male volunteers. Endoscopic evaluation revealed no difference between the two formulations. Since previous studies with enteric coated naproxen tablets indicated a favourable side effect profile compared to plain tablets, the present data indicates that enteric coated formulations are not all alike, and should be studied individually.
Aabakken
L
L
Ullevål Hospital, Department of gastroenterology, Oslo, Norway.
Ugstad
M
M
Gamst
O N
ON
Winther
R
R
Osnes
M
M
D000328:Adult; D002214:Capsules; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004378:Duodenal Diseases / Q000139:chemically induced* / Q000175:diagnosis; D004384:Duodenoscopy; D005773:Gastroscopy; D006801:Humans; D008297:Male; D009288:Naproxen / Q000008:administration & dosage* / Q000009:adverse effects*; D013272:Stomach Diseases / Q000139:chemically induced* / Q000175:diagnosis; D013607:Tablets
D002214:Capsules; D003692:Delayed-Action Preparations; D013607:Tablets; D009288:Naproxen