Evaluation of an enkephalin analog in men with castor oil-induced diarrhea.
This study was a parallel, double-blind, placebo-controlled evaluation of acute doses of nifalatide, an enkephalin analog, in subjects with castor oil-induced diarrhea. Seventy-two subjects completed the study. The time to first stool after castor oil administration was significantly greater after the 16 and 48 mg doses of nifalatide as compared with placebo dosing. The same doses of nifalatide also decreased the overall stool frequency, the frequency of abdominal cramping, and the incidence of nausea and vomiting. There were no clinically significant, drug-related changes in the physical examination results, ECG, vital signs, or clinical laboratory parameters. The only increased adverse experiences that appeared to be related to the drug were dizziness and mild dry mouth.
D000284:Administration, Oral; D000704:Analysis of Variance; D000930:Antidiarrheals / Q000009:adverse effects / Q000627:therapeutic use*; D002368:Castor Oil / Q000009:adverse effects; D003085:Colic / Q000139:chemically induced / Q000188:drug therapy; D003967:Diarrhea / Q000139:chemically induced / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004341:Drug Evaluation; D004744:Enkephalin, Methionine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D011897:Random Allocation
D000930:Antidiarrheals; D004744:Enkephalin, Methionine; C047724:nifalatide; D002368:Castor Oil