Articles: analgesics.
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Randomized Controlled Trial Multicenter Study
Childhood and Adolescent Migraine Prevention (CHAMP) study: a double-blinded, placebo-controlled, comparative effectiveness study of amitriptyline, topiramate, and placebo in the prevention of childhood and adolescent migraine.
Migraine is one of the most common health problems for children and adolescents. If not successfully treated, it can impact patients and families with significant disability due to loss of school, work, and social function. When headaches become frequent, it is essential to try to prevent the headaches. For children and adolescents, this is guided by extrapolation from adult studies, a limited number of small studies in children and adolescents and practitioner preference. The aim of the Childhood and Adolescent Migraine Prevention (CHAMP) study is to determine the most effective preventive agent to use in children and adolescents. ⋯ The goal of the CHAMP study is to obtain level 1 evidence for the effectiveness of amitriptyline and topiramate in the prevention of migraine in children and adolescents. If this study proves to be positive, it will provide information to the practicing physician as how to best prevent migraine in children and adolescents and subsequently improve the disability and outcomes.
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Randomized Controlled Trial Multicenter Study Comparative Study
Comparison of safety outcomes among Caucasian, Hispanic, Black, and Asian patients in duloxetine studies of chronic painful conditions.
This post-hoc analysis was conducted to investigate if safety outcomes differed among race/ethnic subgroups of patients treated with duloxetine for chronic painful conditions. ⋯ Overall, these results detected only minimal differences among safety outcomes assessed in these race/ethnic subgroups in patients treated with duloxetine for chronic painful conditions. The unbalanced sample sizes among the race/ethnic subgroups may have limited the power to detect treatment by race subgroup interactions. These post-hoc subgroup analyses were of an exploratory nature and the results should be interpreted with appropriate caution.
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Multicenter Study
Rationale and design of the Oxycodone Users Registry: a prospective, multicenter registry of patients with nonmalignant pain.
This article describes the rationale and design of the Oxycodone Users Registry (OUR) study and lessons learned during study development and data collection. ⋯ Understanding the rationale, design, and lessons learned from the conduct of the OUR study provides insight that can used in future registry studies.
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Randomized Controlled Trial Multicenter Study
Gastroretentive gabapentin (G-GR) formulation reduces intensity of pain associated with postherpetic neuralgia (PHN).
To evaluate the safety and efficacy of a once-daily gastroretentive formulation of gabapentin (G-GR; 1800 mg). ⋯ Once-daily G-GR 1800 mg was effective and well tolerated for the relief of pain in patients with postherpetic neuralgia.
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Journal of neurology · Apr 2013
Randomized Controlled Trial Multicenter StudyA double-blind, randomized, placebo-controlled, parallel-group study of THC/CBD oromucosal spray in combination with the existing treatment regimen, in the relief of central neuropathic pain in patients with multiple sclerosis.
Central neuropathic pain (CNP) occurs in many multiple sclerosis (MS) patients. The provision of adequate pain relief to these patients can very difficult. Here we report the first phase III placebo-controlled study of the efficacy of the endocannabinoid system modulator delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray (USAN name, nabiximols; Sativex, GW Pharmaceuticals, Salisbury, Wiltshire, UK), to alleviate CNP. ⋯ While there were a large proportion of responders to THC/CBD spray treatment during the phase A double-blind period, the primary endpoint was not met due to a similarly large number of placebo responders. In contrast, there was a marked effect in phase B of the study, with an increased time to treatment failure in the THC/CBD spray group compared to placebo. These findings suggest that further studies are required to explore the full potential of THC/CBD spray in these patients.