Clinical therapeutics
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Clinical therapeutics · Nov 2014
ReviewPalliative care as a primary therapeutic approach in advanced dementia: a narrative review.
The goal of this narrative review was to identify and summarize the ways in which palliative care could benefit patients who have advanced dementia. ⋯ Palliative care has been shown to improve patient and caregiver satisfaction, quality of life, and symptom burden at the end of life. Patients with advanced dementia would benefit from increased access to palliative care.
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Clinical therapeutics · Nov 2014
Randomized Controlled TrialSafety, tolerability and pharmacokinetics of trimebutine 3-thiocarbamoylbenzenesulfonate (GIC-1001) in a randomized phase I integrated design study: single and multiple ascending doses and effect of food in healthy volunteers.
Trimebutine 3-thiocarbamoylbenzenesulfonate (GIC-1001) is a new drug intended to be used for the management of visceral pain in patients undergoing sedation-free, full colonoscopy. The objectives of this Phase I, single-center, randomized, double-blinded, placebo-controlled, integrated study were to evaluate the safety and pharmacokinetics of GIC-1001 after single ascending doses (SAD) and multiple ascending doses (MAD) and to evaluate the influence of food on the pharmacokinetics in healthy volunteers. ⋯ GIC-1001 was well tolerated, and its safety profile was similar to that of placebo. Pharmacokinetics of GIC-1001 and its metabolites were mainly linear and proportional over the studied dose ranges. Steady state was generally considered to be reached after 3 days. Food consumption affected the pharmacokinetic profile of the analytes differently. (ClinicalTrials.gov identifier: NCT01738425.).