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.
Ullevål Hospital, Department of gastroenterology, Oslo, Norway.
L
L
Aabakken
M
M
Ugstad
O N
ON
Gamst
R
R
Winther
M
M
Osnes
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