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.
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Randomized Controlled Trial Clinical Trial
Double-blind controlled clinical study of the efficacy and tolerability of diclofenac-N-(2-hydroxyethyl)-pyrrolidine lecithin gel compared with diclofenac-N-(2-hydroxyethyl)-pyrrolidine gel in patients with peri and extraarticular inflammatory diseases.
To evaluate the efficacy and tolerability of the new diclofenac-N-(2-hydroxyethyl)-pyrrolidine lecithin gel (DHEP lecithin gel, with 1.3% DHEP and 2.4% lecithin) compared with the efficacy and tolerability of diclofenac-N-(2-hydroxyethyl)-pyrrolidine gel (DHEP gel) in peri and extraarticular inflammatory states, a controlled, randomized, double-blind clinical study was conducted. Two groups of 50 patients each were enrolled and were given one of the two different formulations with a slight massage on the painful area three times a day for 10 consecutive days. Patients received a self-evaluation notebook in which to record daily assessment of spontaneous pain (Huskisson's visual analogue scale). ⋯ The efficacy of the active principle, pyrrolidine salt, is confirmed. Moreover, the formulation containing lecithin passes through the skin lipid barrier more easily than the formulation without lecithin and is as valid as the other in the therapy of rheumatic disorders. Finally, DHEP lecithin gel preparation has a quicker therapeutic action on symptoms, such as spontaneous pain and local swelling, than DHEP gel.
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Comparative Study Clinical Trial Controlled Clinical Trial
Fluconazole versus amphotericin B for the prevention of fungal infection in neutropenic patients with hematologic malignancy.
Effective prophylaxis against fungal infection is important in neutropenic patients with hematologic malignancies, but the best method remains unclear. We investigated the effectiveness of fungal prophylaxis with amphotericin B or fluconazole. We reviewed the data on fungal isolates, plasma (1-->3)-beta-D glucan (beta-D glucan) levels, febrile periods (the number of days with an axillary temperature > 38 degrees C), and the duration of an axillary temperature > 38 degrees C when the neutrophil count was < 500/microliter. ⋯ There was a significant decrease of fungal isolates (chi 2-test, p < 0.001), the plasma beta-D glucan level (Wilcoxon test, p = 0.0001), and the febrile period (t-test, p < 0.05) in the patients given fluconazole compared with those given amphotericin B. In neutropenic patients with hematologic malignancies, prophylaxis with fluconazole significantly decreased fungal isolation and other indicators of fungal infection when compared with amphotericin B. Fluconazole may therefore be more effective for fungal prophylaxis in these patients.