Clinical therapeutics
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Clinical therapeutics · Dec 2013
Randomized Controlled TrialCardiac repolarization with Gabapentin enacarbil in a randomized, double-blind, placebo- and active-controlled, crossover thorough QT/QTc study in healthy adults.
Gabapentin enacarbil (GEn) is a prodrug of gabapentin and is approved in the United States in adults for the management of postherpetic neuralgia and in the United States and Japan for the treatment of moderate-to-severe primary restless legs syndrome. ⋯ Single doses of GEn, up to 6000 mg, had no effect on cardiac repolarization in this thorough-QT study and are unlikely to cause clinically relevant QT prolongation in clinical use. Assay sensitivity was confirmed with moxifloxacin as an active control. ClinicalTrials.gov identifier: NCT01516372.
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Clinical therapeutics · Dec 2013
Randomized Controlled TrialEvaluation of the effect of Naloxegol on cardiac repolarization: a randomized, placebo- and positive-controlled crossover thorough QT/QTc study in healthy volunteers.
Opioid-induced constipation (OIC) is a common adverse effect associated with opioid use. Naloxegol is a PEGylated derivative of naloxone in clinical development as a once-daily oral treatment of OIC. ⋯ Naloxegol at 25 and 150 mg was not associated with QT/QTc interval prolongation in these healthy men, and at the proposed therapeutic dose of 25 mg/d, naloxegol is not expected to have a clinically relevant effect on cardiac repolarization in patients with OIC. ClinicalTrials.gov identifier: NCT01325415.
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Clinical therapeutics · Nov 2013
Randomized Controlled Trial Comparative StudyReducing the pain of microemulsion propofol injections: a double-blind, randomized study of three methods of tourniquet and lidocaine.
Although the new formulation of lipid-free microemulsion propofol (MP) has some advantages over the lipid emulsion, it reportedly produces more injection pain than lipid-based propofol. Intravenous lidocaine with application of a rubber tourniquet before administration of propofol is considered to be the best method for reducing injection pain; however, this technique is not perfect. ⋯ UMIN000010725.
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Clinical therapeutics · Nov 2013
Randomized Controlled TrialA randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of the extended-release tramadol hydrochloride/acetaminophen fixed-dose combination tablet for the treatment of chronic low back pain.
Chronic low back pain is a common condition that is often difficult to treat. The combination of tramadol hydrochloride and acetaminophen in an extended-release formulation has been shown to provide rapid and long-lasting analgesic effects resulting from the synergistic activity of these 2 active ingredients. ⋯ TA-ER was significantly more effective than placebo in providing pain relief, functional improvements, and improved quality of life. It exhibited a predictable safety profile in patients with chronic low back pain. ClinicalTrials.gov identifier: NCT01112267.
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Clinical therapeutics · Nov 2013
Randomized Controlled TrialEfficacy of periosteal stimulation for chronic pain associated with advanced knee osteoarthritis: a randomized, controlled clinical trial.
Because of morbidity associated with painful knee osteoarthritis (OA) and commonly prescribed analgesics, patients often pursue complementary and alternative modalities (eg, acupuncture). Clinical trials have demonstrated modest therapeutic efficacy of traditional Chinese acupuncture for knee OA pain, and patients with advanced disease have largely been excluded. We have previously demonstrated preliminary short-term tolerability and efficacy of periosteal stimulation therapy (PST) (ie, electrical stimulation of the periosteum facilitated by acupuncture needles) for older adults with advanced knee OA. ⋯ PST plus PST boosters in patients age >50 with advanced knee OA were well-tolerated and modestly reduced pain. ClinicalTrials.gov identifier: NCT00865046.