Clinical Evaluation of an Oral Analgesic, Z.424, in Patients with Chronic Pain

¹ Second Division of Internal Medicine, Civil Hospital, Alessandria, Italy; Medical Department, Zambon Research Laboratories, Bresso (Milan), Italy.

In two double-blind crossover studies, the analgesic activity and tolerability of the new compound Z.424 (60 mg) was compared to that of codeine (60 mg) and placebo administered orally in single and repeated (t.i.d.) doses to patients with chronic pain. The analgesic activity of Z.424 was significantly greater than that of placebo under the conditions of both studies. The analgesic effect of Z.424 was of the order of that of codeine; in the single dose study, the pain relief (SPID) with Z.424 was significantly less than that with codeine, while with repeated doses Z.424 provided relatively greater analgesia than codeine.

In a third study, which was not controlled, Z.424 was administered orally in doses of 100 to 300 mg daily for five to 16 days to 23 patients with chronic pain and satisfactory relief was reported in 179 out of 229 treatment days. No apparent effects on blood pressure, pulse rate, or respiratory rate were observed during treatment and various laboratory studies done before and after treatment in some patients showed no significant changes. Observations for signs of the withdrawal syndrome were negative.

Tolerability of the new compound was satisfactory; in only one out of 84 patients given repeated doses was treatment discontinued.

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We want to thank Sister Leonzia for her assistance.

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