Articles: analgesics.
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Randomized Controlled Trial Multicenter Study
Pregabalin Does Not Affect Sperm Production in Healthy Volunteers: A Randomized, Double-blind, Placebo-controlled, Noninferiority Study.
The primary objective of this study was to compare the effects of pregabalin and placebo on sperm concentration in healthy male subjects. Changes in follicle-stimulating hormone (FSH), testosterone, sperm motility, semen volume, and sperm morphology were also examined. ⋯ One hundred and nine subjects received placebo and 111 subjects received pregabalin. The difference between placebo and pregabalin with respect to the percentage of subjects with a ≥ 50% reduction from baseline in sperm concentration at End of Study was 6% (95% CI: -2.29 to 14.3%). Noninferiority of pregabalin compared to placebo was declared as the upper bound of the 95% CI was less than the prespecified noninferiority margin of 20%. There were no significant differences between placebo and pregabalin groups with respect to their effects on FSH, testosterone, or sperm motility. Changes in semen volume and sperm morphology were numerically similar in both treatment groups. Adverse events were consistent with the known safety profile of pregabalin. Treatment with 600 mg/day pregabalin for 12 weeks does not adversely affect spermatogenesis or serum levels of FSH and testosterone in healthy males.
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Randomized Controlled Trial Multicenter Study Comparative Study
Initial response as a predictor of 12-week buprenorphine-naloxone treatment response in a prescription opioid-dependent population.
Initial medication response has been shown to predict treatment outcome across a variety of substance use disorders, but no studies have examined the predictive power of initial response to buprenorphine-naloxone in the treatment of prescription opioid dependence. We therefore conducted a secondary analysis of data from the Prescription Opioid Addiction Treatment Study to determine whether initial response to buprenorphine-naloxone predicted 12-week treatment outcome in a prescription opioid-dependent population. ⋯ Evaluating prescription opioid-dependent patients after 2 weeks of buprenorphine-naloxone treatment may help determine the likelihood of successful outcome at completion of the current treatment regimen.
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Multicenter Study
Effects of cabozantinib on pain and narcotic use in patients with castration-resistant prostate cancer: results from a phase 2 nonrandomized expansion cohort.
Pain negatively affects quality of life for cancer patients. Preliminary data in metastatic castration-resistant prostate cancer (mCRPC) suggested a benefit of the oral tyrosine kinase inhibitor cabozantinib to pain palliation. ⋯ We evaluated the potential of cabozantinib to improve symptoms in patients with metastatic prostate cancer that no longer responds to standard therapies. We saw a promising reduction in pain and reduced need for narcotic painkillers. Larger, well-controlled trials are necessary to confirm these findings.
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Randomized Controlled Trial Multicenter Study Comparative Study
Patient controlled analgesia with remifentanil versus epidural analgesia in labour: randomised multicentre equivalence trial.
To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. ⋯ In women in labour, patient controlled analgesia with remifentanil is not equivalent to epidural analgesia with respect to scores on satisfaction with pain relief. Satisfaction with pain relief was significantly higher in women who were allocated to and received epidural analgesia.
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Expert Opin Pharmacother · Jan 2015
Randomized Controlled Trial Multicenter StudyA multicenter, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of single-entity, once-daily hydrocodone tablets in patients with uncontrolled moderate to severe chronic low back pain.
This multicenter, randomized, double-blind, placebo-controlled study with an enriched enrollment, randomized withdrawal design was conducted to evaluate the analgesic efficacy and safety of single-entity, once-daily hydrocodone 20 to 120 mg tablets (HYD) in opioid-naive and opioid-experienced patients with uncontrolled moderate to severe chronic low back pain (CLBP). ⋯ HYD was shown to be an efficacious treatment for CLBP in this study. There were no new or unexpected safety concerns detected.