Comparison of the gastroduodenal tolerance of tenoxicam and diclofenac Na. A double-blind, endoscopically controlled study in healthy volunteers

Abstract

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.