Clinical drug investigation
-
Randomized Controlled Trial Multicenter Study
Antihypertensive efficacy and safety of manidipine versus amlodipine in elderly subjects with isolated systolic hypertension: MAISH study.
Isolated systolic hypertension (ISH) affects 10-20% of the elderly population and is strongly related to the risk of cardiovascular events. Elevated systolic BP values are primarily caused by reduced large vessel compliance with a consequent increase in total peripheral resistance. Vasodilating drugs, such as calcium channel antagonists, have proven to be effective in controlling ISH in elderly patients. This study set out to compare the antihypertensive efficacy and safety of two different calcium channel antagonists, manidipine and amlodipine, administered once daily in elderly subjects with ISH. ⋯ In elderly patients with ISH, treatment with manidipine for 12 weeks was well tolerated and effective and the antihypertensive effects obtained with manidipine were the same as those obtained with amlodipine.
-
Randomized Controlled Trial Multicenter Study Comparative Study
A multicentre, randomised, double-blind study comparing the efficacy and tolerability of intramuscular dexketoprofen versus diclofenac in the symptomatic treatment of acute low back pain.
Low back pain is an important medical problem in Western industrialised countries. NSAIDs are one of the main options for symptomatic pain relief in the early management of this painful condition. Dexketoprofen is an NSAID belonging to the arylpropionic acid group that has demonstrated good analgesic efficacy and a good safety profile in different acute and chronic painful conditions. ⋯ From the results of this study it can be concluded that dexketoprofen 50mg administered twice daily intramuscularly provides a clinically relevant analgesic effect with good tolerability after single and repeated doses in patients with acute severe low back pain.
-
Multicenter Study Clinical Trial
Efficacy and tolerability of oxycodone hydrochloride controlled-release tablets in moderate to severe cancer pain.
Oxycodone is a semisynthetic opioid analgesic drug classed as a strong opioid. The controlled-release oxycodone tablet formulation (OCRT) was approved in China in 2004 for management of moderate to severe cancer pain. Few data about the efficacy of OCRT and clinical outcomes in Chinese patients taking this drug are available. The purpose of this study was to evaluate the efficacy and tolerability of this drug for relief of moderate to severe cancer pain in Chinese patients. ⋯ We conclude that OCRT is well tolerated and effective in controlling moderate to severe cancer pain in Chinese patients.
-
Multicenter Study
Absorption of fentanyl from fentanyl buccal tablet in cancer patients with or without oral mucositis: a pilot study.
Patients with cancer, particularly those undergoing chemotherapy or radiotherapy, may develop oral mucositis. This is the first study to investigate the absorption profile of fentanyl buccal tablet (FBT) - an effervescent formulation of fentanyl indicated for the management of breakthrough pain in opioid-tolerant cancer patients - in patients with or without oral mucositis. ⋯ The absorption profile of a single dose of FBT 200 microg was similar in patients with or without mild oral mucositis. The compound was generally well tolerated.
-
Clinical Trial
Topical application of dexamethasone to prevent cerebral vasospasm after aneurysmal subarachnoid haemorrhage: a pilot study.
Cerebral vasospasm is a common and serious complication of aneurysmal subarachnoid haemorrhage (SAH). Many studies have revealed a role of inflammation in the development of cerebral vasospasm. This study aimed to investigate whether topically administered dexamethasone could attenuate vasospasm in SAH patients. ⋯ Topical application of dexamethasone is a promising strategy for prevention and attenuation of vasospasm following aneurysmal SAH.