Clinical therapeutics
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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.
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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 · Jul 2015
Randomized Controlled TrialEffects of Food Intake on the Relative Bioavailability of Amifampridine Phosphate Salt in Healthy Adults.
Amifampridine (3,4-diaminopyridine) has been approved in the European Union for the treatment of Lambert-Eaton myasthenic syndrome. Amifampridine has a narrow therapeutic index, and supratherapeutic exposure has been associated with dose-dependent adverse events, including an increased risk for seizure. This study assessed the effect of food on the relative bioavailability of amifampridine in healthy subjects and informed on conditions that can alter exposure. ⋯ At the intended dose under fasting conditions, amifampridine exposure may be increased. European Union Drug Regulating Authorities Clinical Trials identifier: 2011-000596-13.
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Clinical therapeutics · Jul 2015
Randomized Controlled TrialEffect of Retosiban on Cardiac Repolarization in a Randomized, Placebo- and Positive-controlled, Crossover Thorough QT/QTc Study in Healthy Men and Women.
Retosiban is a small molecule oxytocin receptor antagonist that is under evaluation in clinical studies for treatment of spontaneous preterm labor. A Thorough QT/QTc study was conducted to evaluate the effect of retosiban on cardiac repolarization according to International Conference on Harmonization E14 guidance. This was a randomized, placebo- and positive-controlled, single-dose, crossover study of healthy men and women. ⋯ NCT01702376.
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Clinical therapeutics · May 2015
Randomized Controlled TrialEffect of Intraoperative Dexmedetomidine on Post-Craniotomy Pain.
Pain management for patients who have undergone a craniotomy remains challenging. This study aimed to determine whether intraoperative dexmedetomidine could reduce postoperative pain, analgesic consumption, and possible adverse events in patients after craniotomy. ⋯ Intraoperative dexmedetomidine infusion was effective for reducing pain and analgesic consumption after craniotomy. In addition, dexmedetomidine may help to reduce PONV in patients after craniotomy treated with tramadol postoperatively. Chinese Clinical Trial Register identifier: ChiCTR-TRC-13003598.