Double-dummy comparison of suprofen and indometacin sustained release formulations.

In a randomized double-dummy study a new dosage form of alpha-methyl-4-(2-thienyl-carbonyl)phenylacetic acid (suprofen, Suprol), i.e., suprofen sustained release 600 mg tablets, was compared with indometacin sustained release 75 mg capsules. The test population included 60 hospitalized subjects in severe chronic pain requiring analgesic treatment. The treatment groups were homogeneous as to their anamnestic data. Treatment was given for 3 weeks; the drugs were uniformly administered in the morning and in the evening. The intensity of pain was assessed using a visual analog scale (VAS) prior to administration of the first dose on day 1 of the therapy, and then for up to 10 h. Further assessments of pain intensity and pain relief were obtained after 1, 2, and 3 weeks of therapy. Comparison of the mean pain intensity (VAS) at the individual rating times revealed statistically significant better pain relief with suprofen than with indometacin already 1 h after the administration (p less than 0.05, multivariate analysis of variance). This statistically significant difference as compared with indometacin was confirmed at all subsequent time points. The weekly assessments of pain intensity showed that the results obtained with suprofen were superior to those with indometacin, although they were not statistically significant. However, pain relief after 2 weeks' treatment with suprofen was significantly superior (p = 0.0061, exact test) to the result observed with indometacin. The results obtained with suprofen in weeks 1 and 3 were superior to those with indometacin, but they were not statistically significant.(ABSTRACT TRUNCATED AT 250 WORDS)