Articles: analgesics.
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Randomized Controlled Trial Multicenter Study
Lenalidomide for complex regional pain syndrome type 1: lack of efficacy in a phase II randomized study.
Complex regional pain syndrome (CRPS) is a potentially debilitating chronic pain syndrome with a poorly understood but likely neuroimmune/multifactorial pathophysiology associated with axonal injury. Based on the potential contribution of proinflammatory cytokines to CRPS pathogenesis and prior research with thalidomide, we investigated lenalidomide, a thalidomide derivative, for CRPS treatment. We conducted a phase II, randomized, double-blind, placebo-controlled study to evaluate the efficacy of oral lenalidomide 10 mg once daily in consenting patients with unilateral or bilateral CRPS type 1. The study comprised 12 weeks of treatment followed by a long-term extension. The primary efficacy outcome was reduced pain in the index limb, defined as ≥30% improvement from baseline using an 11-point numeric rating scale. One hundred eighty-four subjects enrolled. The primary endpoint was not met because equal proportions of treated (16.1%) and control (16.1%) subjects achieved the outcome; however, lenalidomide was well tolerated, with no evidence of neuropathy or major adverse effects. This study is the largest controlled, blinded clinical trial in subjects with chronic CRPS using the Budapest research criteria. It demonstrates the feasibility of conducting high-quality clinical trials in CRPS type 1 and provides considerations for designing future trials. ⋯ This article reports an adequately powered, controlled clinical trial in subjects with CRPS. Treatment and placebo were equally effective, but the study demonstrated that lenalidomide treatment is feasible in this population. The study provides examples to consider in designing future CRPS trials.
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J Pain Palliat Care Pharmacother · Dec 2014
Multicenter Study Clinical TrialPharmacokinetics of oxycodone after intravenous and subcutaneous administration in Japanese patients with cancer pain.
ABSTRACT In Japan, Oxycodone hydrochloride injection formulation has been approved in 2012. However, its pharmacokinetics has been poorly studied. The aim of this study is to evaluate the pharmacokinetics of oxycodone after intravenous and subcutaneous administration of oxycodone hydrochloride injection in Japanese patients with cancer pain. ⋯ The estimated geometric mean clearance (CL) of oxycodone was 24.3 L per hour after constant intravenous infusion and 29.5 L per hour after constant subcutaneous infusion, respectively. Population pharmacokinetic analysis indicated that body surface area was the influencing factor on CL and there were no pharmacokinetic differences for CL between intravenous and subcutaneous infusion. These results provide important information for the clinical use of oxycodone injection.
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Neurogastroenterol. Motil. · Dec 2014
Randomized Controlled Trial Multicenter StudyLong-term evaluation of combined prolonged-release oxycodone and naloxone in patients with moderate-to-severe chronic pain: pooled analysis of extension phases of two Phase III trials.
While opioids provide effective analgesia, opioid-induced constipation (OIC) can severely impact quality of life and treatment compliance. This pooled analysis evaluated the maintenance of efficacy and safety during long-term treatment with combined oxycodone/naloxone prolonged-release tablets (OXN PR) in adults with moderate-to-severe chronic pain. ⋯ Pooled data demonstrate OXN PR is an effective long-term therapy for patients with chronic non-cancer pain, and can address symptoms of OIC. No new safety issues were observed which were attributable to the long-term administration of OXN PR.
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Multicenter Study
Classifying fibromyalgia patients according to severity: the combined index of severity in fibromyalgia.
The aim of this study was to establish the cutoff points in the Combined Index of Fibromyalgia Severity (ICAF) questionnaire which allow classification of patients by severity and to evaluate its application in the clinical practice. The cutoff points were calculated using the area under the ROC curve in two cohorts of patients. Three visits, basal, fourth month and 15th month, were considered. ⋯ The patients with more passive coping factor showed highest punctuations in the remaining scores and were more prevalent in the severe category. The patients with a predominance of the emotional factor showed a better response at the end of follow-up. The established cutoff points allow the classification of FM patients by severity, to know the prognostic and to predict the response to the treatment.
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Multicenter Study Observational Study
Add-on treatment with pregabalin for patients with uncontrolled neuropathic pain who have been referred to pain clinics.
The aim of this study was to investigate the impact of pregabalin on pain, other symptoms, and patient-reported outcomes for patients with uncontrolled pain who have been referred to pain clinics. ⋯ Our results suggest that in patients with uncontrolled neuropathic pain of various origins who were treated at pain clinics, the addition of pregabalin to a wider pharmacological treatment regimen was associated with a clinically relevant improvement of pain and psychological well-being and a reduction in the impact of neuropathic pain on daily activities. Add-on treatment with pregabalin was well tolerated.