Clinical therapeutics
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Clinical therapeutics · Oct 2009
Randomized Controlled Trial Comparative StudyComparison of the pharmacokinetics of ticlopidine between administration of a combined fixed-dose tablet formulation of ticlopidine 250 mg/ginkgo extract 80 mg, and concomitant administration of ticlopidine 250-mg and ginkgo extract 80-mg tablets: an open-label, two-treatment, single-dose, randomized-sequence crossover study in healthy Korean male volunteers.
Ticlopidine is an antiplatelet agent used for the prevention of vascular accidents. In clinical practice in Korea, ginkgo extract may be administered along with ticlopidine to enhance the inhibition of platelet aggregation. ⋯ Administration of a single dose of a combined fixed-dose formulation of ticlopidine 250 mg/ ginkgo extract 80-mg tablets and concomitant administration of ticlopidine and ginkgo extract tablets did not result in statistically significant differences in the pharmacokinetics of ticlopidine in these healthy Korean male volunteers.
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Clinical therapeutics · Oct 2009
Randomized Controlled TrialEffects of food intake on the pharmacokinetics of diclofenac potassium soft gelatin capsules: a single-dose, randomized, two-way crossover study.
Diclofenac potassium liquid-filled soft gelatin capsule (DPSGC) is an investigational formulation that uses dispersing agents designed to facilitate rapid and consistent absorption of this NSAID. ⋯ Food intake did not appear to affect the extent of absorption (ie, total exposure) of oral DPSGC at doses of 25 and 50 mg in these healthy adult volunteers. Both single doses appeared to be well tolerated.
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Clinical therapeutics · Oct 2009
Letter Clinical TrialLow doses of transdermal buprenorphine in opioid-naive patients with cancer pain: a 4-week, nonrandomized, open-label, uncontrolled observational study.
The aim of this study was to evaluate the effect and tolerability of low doses of transdermal (TD) buprenorphine patches in opioid-naive patients with cancer pain. ⋯ Observations from this study suggest that randomized, controlled, double-blind studies of TD buprenorphine 17.5 microg/h in opioid-naive patients with cancer pain may be warranted.
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Clinical therapeutics · Sep 2009
Randomized Controlled Trial Multicenter Study Comparative StudyA multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen 400 and 800 mg every 6 hours in the management of postoperative pain.
Although opioids are the mainstay of inpatient postoperative pain management, they do not block inflammation. The NSAID ibuprofen has antiinflammatory and analgesic properties, and a multimodal approach may reduce opioid requirements. ⋯ In these patients undergoing postoperative pain management, ibuprofen 800 mg IV q6h was associated with significant reductions in morphine use and pain at rest and with movement compared with placebo. Ibuprofen IV was not associated with significant increases in AEs compared with placebo, with the exception of dizziness with the 800-mg dose. These findings suggest that ibuprofen 800 mg IV q6h was effective for postoperative pain management and was generally well tolerated. ClinicalTrials.gov identifier: NCT00225732.
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Clinical therapeutics · Sep 2009
Comparative StudyEfficacy and tolerability of nebivolol monotherapy by baseline systolic blood pressure: a retrospective analysis of pooled data from two multicenter, 12-week, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging studies in patients with mild to moderate essential hypertension.
In clinical studies, nebivolol at doses of 2.5 to 40 mg once daily was associated with significant decreases in systolic blood pressure (SBP) and diastolic BP (DBP) in patients with hypertension and was well tolerated. ⋯ The present analysis of pooled data from 2 previously published registration studies found that nebivolol was associated with significant reductions in BP compared with placebo in these patients with stage 1 or 2 hypertension, with a tolerability similar to that of placebo.