Current medical research and opinion
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Randomized Controlled Trial Multicenter Study
A randomized, double-blind, placebo-controlled phase 3 study of the relative efficacy and tolerability of tapentadol IR and oxycodone IR for acute pain.
To evaluate the relative efficacy and tolerability of tapentadol immediate release (IR) and oxycodone IR for management of moderate to severe pain following orthopedic surgery (bunionectomy). ⋯ Clinically meaningful and statistically significant improvements were observed with tapentadol IR 50 mg and 75 mg compared with placebo for the relief of moderate-to-severe acute pain after orthopedic surgery. Tapentadol IR 50 mg and 75 mg were non-inferior to oxycodone HCl IR 10 mg for the treatment of acute pain based on the primary efficacy endpoint of SPID(48) and the pre-specified margin of 48 points. The incidence of nausea and/or vomiting was statistically significantly lower for tapentadol IR 50 mg and numerically lower for tapentadol IR 75 mg than for oxycodone HCl IR 10 mg.
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Randomized Controlled Trial Multicenter Study
Cyclobenzaprine ER for muscle spasm associated with low back and neck pain: two randomized, double-blind, placebo-controlled studies of identical design.
To evaluate efficacy and tolerability of once-daily cyclobenzaprine extended release (CER) 15- and 30-mg capsules in patients with muscle spasm associated with acute, painful musculoskeletal conditions. ⋯ Once-daily CER 15 mg (study 2) and CER 30 mg (study 1) were effective in treating muscle spasm associated with painful musculoskeletal conditions after 4 days of treatment. Differences between CER and placebo groups did not reach statistical significance on all efficacy measures, and the protocols were not powered to detect differences between active treatment arms. CER was generally safe and well tolerated, with low rates of somnolence.
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Randomized Controlled Trial Multicenter Study
Tolerability of tapentadol immediate release in patients with lower back pain or osteoarthritis of the hip or knee over 90 days: a randomized, double-blind study.
Tapentadol is a novel, centrally acting analgesic with two mechanisms of action, mu-opioid receptor agonism and norepinephrine reuptake inhibition, in a single molecule. This phase III, randomized, double-blind, active-controlled study evaluated the tolerability of tapentadol immediate release (IR) and oxycodone IR for low back pain or osteoarthritis pain (hip or knee), using flexible dosing over 90 days. ⋯ During this 90-day study, tapentadol IR was associated with improved gastrointestinal tolerability compared with oxycodone IR while providing similar pain relief. Trial registration information: NCT00364546.
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Randomized Controlled Trial Multicenter Study
Efficacy and safety of therapy with metformin plus pioglitazone in the treatment of patients with type 2 diabetes: a double-blind, placebo-controlled, clinical trial.
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Multicenter Study
Efficacy and tolerability of a 5% lidocaine medicated plaster for the topical treatment of post-herpetic neuralgia: results of a long-term study.
Evaluation of long-term efficacy and safety of the 5% lidocaine medicated plaster for neuropathic pain symptoms in patients with post-herpetic neuralgia (PHN). ⋯ This study suggests that long-term treatment with the 5% lidocaine medicated plaster may provide substantial and maintained reductions in pain intensity, and that it is continuously well tolerated in patients suffering from peripheral neuropathic pain associated with previous herpes zoster infection. These findings support the use of the 5% lidocaine medicated plaster as one of the first-line therapies in this population.