Comparison of the gastroduodenal tolerance of tenoxicam and diclofenac Na. A double-blind, endoscopically controlled study in healthy volunteers.
The gastroduodenal tolerance of Tenoxicam and Diclofenac Na has been evaluated in a double-blind, parallel group study in 36 healthy male volunteers. The doses used were 20 mg Tenoxicam and 100 mg Diclofenac Na daily in a retard formulation for 14 days. Gastric tolerance was assessed by endoscopy, which was performed at base-line, after the 14 day dosing period and after a 14 day follow-up period without treatment. The mucosal lesions were scored using modified Lanza criteria. Tenoxicam was significantly better tolerated at the end of the 14 day dosing period (mean gastric score: Tenoxicam 1.3; Diclofenac Na 2.2). The two treatment groups had comparable scores at the base-line and post study assessments. Tenoxicam and Diclofenac Na were generally well tolerated. Only two volunteers reported intermittant lack of appetite, heartburn and a feeling of pressure in the stomach.
Müller
P
P
Gastroenterologische Abteilung, Medizinische Universitätsklinik Heidelberg, Federal Republic of Germany.
Dammann
H G
HG
Leucht
U
U
Simon
B
B
D000293:Adolescent; D000328:Adult; D004008:Diclofenac / Q000009:adverse effects*; D004311:Double-Blind Method; D004386:Duodenum / Q000187:drug effects; D005767:Gastrointestinal Diseases / Q000139:chemically induced*; D005773:Gastroscopy; D006801:Humans; D008297:Male; D010894:Piroxicam / Q000009:adverse effects / Q000031:analogs & derivatives*; D011897:Random Allocation; D013270:Stomach / Q000187:drug effects; D013997:Time Factors
D010894:Piroxicam; D004008:Diclofenac; C032801:tenoxicam