Articles: analgesics.
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Randomized Controlled Trial Multicenter Study
A randomized, placebo-controlled phase 3 trial (Study SB-767905/013) of alvimopan for opioid-induced bowel dysfunction in patients with non-cancer pain.
The balance between the pain relief provided by opioid analgesics and the side effects caused by such agents is of particular significance to patients who take opioids for the long-term relief of non-cancer pain. The spectrum of signs and symptoms affecting the gastrointestinal (GI) tract associated with opioid use is known as opioid-induced bowel dysfunction. Alvimopan is an orally administered, systemically available, peripherally acting mu-opioid receptor (PAM-OR) antagonist, approved in the US for the management of postoperative ileus in patients undergoing bowel resection (short-term, in-hospital use only). Alvimopan was under clinical development for long-term treatment of opioid-induced constipation (OIC) but this program has been discontinued. This double-blind, placebo-controlled trial, part of the former OIC development program, enrolled patients (N = 485) receiving opioids for non-cancer pain. Patients were randomized to receive alvimopan .5 mg once daily, alvimopan .5 mg twice daily, or placebo, for 12 weeks. The primary efficacy endpoint was the proportion of patients who experienced ≥ 3 spontaneous bowel movements (SBMs; bowel movements with no laxative use in the previous 24 hours) per week over the treatment period, and an average increase from baseline of ≥ 1 SBM per week. There were greater proportions of SBM responders in both alvimopan treatment groups (63% in both groups) compared with placebo (56%), although these differences were not statistically significant. Secondary efficacy analyses indicated that alvimopan was numerically superior to placebo in improving opioid-induced bowel dysfunction symptoms and patients' global assessment of opioid-induced bowel dysfunction, and reduced the requirement for rescue laxatives. Active treatment was well tolerated and alvimopan did not antagonize opioid analgesia. ⋯ Although the primary endpoint was not met in this study, the magnitude of alvimopan-induced improvements versus baseline, together with previous study results, suggest that a PAM-OR antagonist has the potential to improve OIC.
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J Pain Symptom Manage · Feb 2011
Randomized Controlled Trial Multicenter StudyConsistency of efficacy, patient acceptability, and nasal tolerability of fentanyl pectin nasal spray compared with immediate-release morphine sulfate in breakthrough cancer pain.
We recently reported that fentanyl pectin nasal spray (FPNS) provides superior pain relief from breakthrough cancer pain (BTCP) compared with immediate-release morphine sulfate (IRMS), with significant effects by five minutes and clinically meaningful pain relief from 10 minutes postdose. ⋯ This study demonstrates that FPNS is efficacious, well accepted, and well tolerated by patients with BTCP.
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Clinical therapeutics · Feb 2011
Randomized Controlled Trial Multicenter StudyEfficacy of pregabalin for peripheral neuropathic pain: results of an 8-week, flexible-dose, double-blind, placebo-controlled study conducted in China.
Several classes of medications such as tricyclic antidepressants, anticonvulsants, narcotic analgesics, and α2-δ ligands, such as pregabalin, have been reported to be efficacious in the treatment of painful diabetic peripheral neuropathy (DPN) and postherpetic neuralgia (PHN) in whites. However, no large double-blind, placebo-controlled trials have been reported that evaluated the efficacy of pregabalin for the treatment of neuropathic pain in a Chinese population in China. ⋯ Study results suggest that relative to placebo, pregabalin in daily doses of 150 to 600 mg/d was effective and well tolerated in Chinese patients diagnosed with moderate-to-severe DPN or PHN, indicated through improved pain scores and PGIC scores.
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Randomized Controlled Trial Multicenter Study Comparative Study
PCA analgesia for children with chemotherapy-related mucositis: a double-blind randomized comparison of morphine and pethidine.
This study aimed to compare pethidine and morphine on efficacy and toxicity in children with severe mucositis following chemotherapies. ⋯ PCA with pethidine appears not inferior to morphine, with less constipation requiring specific treatment, but a larger study is warranted to confirm this.
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Multicenter Study Comparative Study Clinical Trial
[Application of a seven-day buprenorphine transdermal patch in multimorbid patients on long-term ibuprofen or diclofenac].
The objective of this study was to evaluate the benefit of a seven-day buprenorphine transdermal patch for patients with chronic musculoskeletal pain previously receiving long-term treatment with ibuprofen or diclofenac alone. Data of a subgroup of 703 patients were analysed which were part of a multicenter observational study with 3,295 patients. These patients had previously received ibuprofen or diclofenac and were characterized by older age,the presence of gastrointestinal, cardiovascular, and renal risk factors and the existence of chronic musculoskeletal pain. ⋯ In addition, particularly multimorbid patients benefit from opioids such as buprenorphine due to the lack of cardiac, renal and gastrointestinal toxicity. Constant analgesia, improvement of daily activities and reduction of tablets were reported as important advantages of the seven-day patch. In conclusion, the seven-day buprenorphine patch is a valuable therapeutic option for patients with insufficient analgesia on long-term ibuprofen or diclofenac.