Clinical therapeutics
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Clinical therapeutics · Aug 2015
Randomized Controlled TrialSafety and Efficacy of a Needle-free Powder Lidocaine Delivery System in Pediatric Patients Undergoing Venipuncture or Peripheral Venous Cannulation: Randomized Double-blind COMFORT-004 Trial.
The goal of this study was to determine if a lidocaine hydrochloride monohydrate powder intradermal system designed to provide cutaneous analgesia is efficacious, safe, and tolerable for pediatric subjects compared with a sham placebo system. ⋯ The needle-free powder lidocaine delivery system was well tolerated and produced superior analgesia compared with sham placebo when administered 1-3 minutes before pediatric venipuncture or peripheral venous cannulation. Treatment-related AEs occurred primarily at the administration site and were infrequent, generally mild, and resolved without sequelae. ClinicalTrials.gov identifier: NCT00140088.
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Clinical therapeutics · Aug 2015
Randomized Controlled TrialEmpagliflozin as Add-on Therapy to Pioglitazone With or Without Metformin in Patients With Type 2 Diabetes Mellitus.
To investigate the long-term efficacy and safety of empagliflozin as add-on therapy to pioglitazone with or without metformin in patients with type 2 diabetes mellitus. ⋯ Empagliflozin 10 mg or 25 mg as add-on therapy to pioglitazone with or without metformin for 76 weeks was well tolerated and led to sustained reductions in HbA1c and weight compared with placebo in patients with type 2 diabetes. ClinicalTrials.gov identifier: NCT01210001.