Piroxicam-beta-cyclodextrin: effects on gastrointestinal blood loss and gastric mucosal appearance in healthy men.
Thirty-six healthy men aged 20-31 years took part in a randomized, double-blind, double-dummy, parallel-group study to compare the effects of repeated doses of piroxicam-beta-cyclodextrin, piroxicam and placebo on faecal blood loss and the endoscopic appearances of gastric and duodenal mucosa. After an initial endoscopy, subjects received on day 0 autologous erythrocytes labelled with 51Cr. Complete daily faecal collections were then made from days 6 to 12. From days 13 to 40, subjects received daily by mouth either piroxicam-beta-cyclodextrin (containing 20 mg piroxicam), piroxicam 20 mg, or placebo. Complete faecal collections were made daily from days 13 to 41; blood samples for red-cell 51Cr activity were taken weekly. Endoscopy was repeated 16-20 h after the last dose of medication. Faecal blood loss was calculated from 51Cr activity of blood and faeces. Compliance with medication was confirmed by blood sampling on days 20, 27 and 34. General tolerability of the medication was good, although 1 subject was withdrawn from piroxicam-beta-cyclodextrin and 1 from piroxicam treatment because of abdominal pain. There were no clinically significant changes in haematology, biochemistry or urinalysis results in any subject. Endoscopic appearances deteriorated moderately in 3 subjects receiving piroxicam and 3 receiving piroxicam-beta-cyclodextrin, but did not deteriorate in any subject receiving placebo. There was a trend for cumulative blood loss to be higher for piroxicam than for the other treatments in the last 12 days of dosing.(ABSTRACT TRUNCATED AT 250 WORDS)
Warrington
S
S
Charterhouse Clinical Research Unit Limited, London, UK.
Debbas
N
N
Farthing
M
M
Horton
M
M
Umile
A
A
D000284:Administration, Oral; D000328:Adult; D002860:Chromium Radioisotopes / Q000032:analysis / Q000097:blood; D003505:Cyclodextrins / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D004064:Digestive System / Q000187:drug effects* / Q000473:pathology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004338:Drug Combinations; D004724:Endoscopy; D004912:Erythrocytes / Q000737:chemistry; D005243:Feces / Q000737:chemistry; D005753:Gastric Mucosa / Q000187:drug effects* / Q000473:pathology; D006471:Gastrointestinal Hemorrhage / Q000209:etiology*; D006801:Humans; D008297:Male; D010894:Piroxicam / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D047392:beta-Cyclodextrins
D002860:Chromium Radioisotopes; D003505:Cyclodextrins; D004338:Drug Combinations; D047392:beta-Cyclodextrins; D010894:Piroxicam; C031215:betadex