Comparison of faecal blood loss, upper gastrointestinal mucosal integrity and symptoms after piroxicam beta-cyclodextrin, piroxicam and placebo administration.
In order to evaluate the gastric tolerance of the new piroxicam formulation CHF 1194 (piroxicam complexed with beta-cyclodextrin), a double-blind randomized trial was carried out in 21 young healthy volunteers comparing CHF 1194 with piroxicam and placebo. Faecal blood loss measurement by the Cr-51 labelled red blood cell technique, upper gastrointestinal endoscopic evaluation, titration of gastric pH and gastric biopsies before, during and after treatment were used to assess drug tolerability. Four out of 7 volunteers in the piroxicam-treated group withdrew because of severe gastrointestinal symptoms and oesophageal and/or gastroduodenal lesions, while all subjects treated with CHF 1194 or placebo completed the treatment. There was a significant difference between the endoscopic scores of the piroxicam and placebo groups, whereas no differences were found between CHF 1194 and placebo, nor between piroxicam and CHF 1194. Daily mean gastrointestinal blood loss was greater in the piroxicam group than in either the CHF 1194 or placebo groups, but the difference was not significant, due to the small number of piroxicam-treated subjects who completed the study. When administered for a short period to healthy young subjects, CHF 1194 caused less gastric damage and was better tolerated than piroxicam.
Patoia
L
L
Istituto di Clinica Medica 1, Cattedra di Terapia Medica e, Parma, Italy.
Clausi
G
G
Farroni
F
F
Alberti
P
P
Fugiani
P
P
Bufalino
L
L
D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D002986:Clinical Trials as Topic; D003505:Cyclodextrins / Q000009:adverse effects*; D003912:Dextrins / Q000009:adverse effects*; D004311:Double-Blind Method; D004338:Drug Combinations / Q000009:adverse effects; D005260:Female; D005753:Gastric Mucosa / Q000187:drug effects* / Q000473:pathology; D006471:Gastrointestinal Hemorrhage / Q000139:chemically induced*; D005773:Gastroscopy; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D010894:Piroxicam / Q000009:adverse effects*; D011897:Random Allocation; D013213:Starch / Q000009:adverse effects*; D047392:beta-Cyclodextrins
D000894:Anti-Inflammatory Agents, Non-Steroidal; D003505:Cyclodextrins; D003912:Dextrins; D004338:Drug Combinations; D047392:beta-Cyclodextrins; D010894:Piroxicam; D013213:Starch; C061072:piroxicam-beta-cyclodextrin