A multiclinic trial evaluating arbaprostil [15(R)-15-methyl prostaglandin E2] as a therapeutic agent for gastric ulcer.
A randomized, double-blind, placebo-controlled, multiclinic trial evaluated arbaprostil [15(R)-15 methyl prostaglandin E2] for the treatment of acute gastric ulcer, achieving an overall enrollment of 124 patients (of which 113 were considered evaluable). This 6-wk trial used an arbaprostil dose of 10 micrograms q.i.d., which has little gastric acid antisecretory activity. Endoscopies were performed after 21 and 42 days of treatment, at which times the arbaprostil and placebo healing rates, respectively, were 6/59 (10.2%) and 4/53 (7.6%) on day 21 and 25/59 (42.4%) and 16/50 (32.0%) on day 42. No significant differences between the treatment groups were found for pain relief, antacid consumption, and mucosal healing. This trial documents that a 10-micrograms dose of arbaprostil (which may be considered cytoprotective because of its small effect on gastric acid secretion), although safe and associated with no side effects, is not efficacious in healing acute gastric ulcers.
Euler
A R
AR
Clinical Development Unit, Upjohn Company, Kalamazoo, Michigan.
Popiela
T
T
Tytgat
G N
GN
Kulig
J
J
Lookabaugh
J L
JL
Phan
T D
TD
Kitt
M M
MM
D000208:Acute Disease; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001101:Arbaprostil / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005260:Female; D005753:Gastric Mucosa / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D011459:Prostaglandins E, Synthetic / Q000627:therapeutic use*; D011897:Random Allocation; D013276:Stomach Ulcer / Q000188:drug therapy* / Q000473:pathology
D011459:Prostaglandins E, Synthetic; D001101:Arbaprostil