Drugs under experimental and clinical research
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Randomized Controlled Trial Clinical Trial
Treatment of knee osteoarthritis with a topical non-steroidal antiinflammatory drug. Results of a randomized, double-blind, placebo-controlled study on the efficacy and safety of a 5% ibuprofen cream.
The efficacy and safety of a 5% ibuprofen cream (Dolgit cream) in primary knee osteoarthritis was assessed in this double-blind, randomized, placebo-controlled, parallel-group study with an adaptive sequential design. The background of the study was the need to confirm the efficacy of ibuprofen cream. Patients aged 40-75 years, with a visual analog scale (VAS) score of pain on motion of 40 mm, a Lequesne index score of 5-13 points, and a Kellgren and Lawrence radiographic score of grade II-III were enrolled between September 1999 and November 2000. ⋯ All secondary endpoints, pain at rest, pain on pressure, Lequesne index and overall assessment, also confirmed the statistically significant differences between the groups. No drug-related adverse events were recorded. The study confirmed the efficacy of ibuprofen cream by demonstrating its statistically significant and clinically relevant superiority over the placebo cream in the treatment of primary knee osteoarthritis.
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A prospective, randomized, placebo-controlled, multicenter, double-blind trial in fibromyalgia patients demonstrated that peroral daily treatment with 5 mg tropisetron for 10 days produced a significant reduction in pain and other symptoms. The aim of the present study was to determine whether intravenous administration of 2 mg tropisetron daily for a limited period of time would produce quicker and more favorable results. In the first cohort 18 fibromyalgia patients received a single intravenous injection of 2 mg tropisetron. ⋯ Tolerability was good. In conclusion, intravenous injection of 2 mg of the 5-hydroxytryptamine3 receptor antagonist tropisetron once daily for 5 days produced a longer-lasting therapeutic effect on fibromyalgia symptoms than did peroral daily treatment with 5 mg of this drug. The results achieved are currently being evaluated in a randomized, placebo-controlled, double-blind trial.
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Clinical Trial
Effects of topical diclofenac (DHEP plaster) on skin, subcutis and muscle pain thresholds in subjects without spontaneous pain.
The aim of this study was to determine whether topical application of diclofenac hydroxyethylpyrrolidine (DHEP) modifies somatic pain sensitivity in subjects without spontaneous pain. Twenty male subjects (aged 19-40 years), who had not reported any pain for at least 1 month, underwent measurement of pain thresholds to bilateral electrical stimulation in the quadriceps muscle and overlying subcutis and skin. Following the double-blind study design, one diclofenac adhesive plaster (13 x 10 cm; 180 mg DHEP) was then applied over one quadriceps while a matched placebo plaster was placed contralaterally. ⋯ In contrast, muscle thresholds significantly increased after diclofenac compared with placebo treatment (group 1: p < 0.05; group 2: p < 0.007); the increase was significantly higher in group 2 than in group 1 (p < 0.002). Topical application of diclofenac had a selective hypoalgesic effect on muscles, which was more pronounced in the case of hyperalgesia. These results suggest that the preparation is particularly effective in the treatment of algogenic conditions of deep somatic tissues.