Abstract:
BACKGROUND AND OBJECTIVE:The use of transdermal fentanyl for opioid-naïve patients is restricted, however, transdermal fentanyl is a useful opioid analgesic for patients in whom oral administration is difficult or for those with renal failure. In this study, the efficacy and safety of fentanyl citrate patches was evaluated in opioid-naïve patients suffering from cancer pain. METHODS:An open-label uncontrolled study was conducted in opioid-naïve patients with cancer pain unable to be controlled by non-opioid analgesics. Fentanyl citrate patches starting at a low dose (0.5 mg/patch, corresponding to 6.25 μg/h fentanyl delivered) were applied once/day for up to 14 days. The analgesic effect was assessed every day from the visual analogue scale pain score and the number of doses of rescue medication. When improvement of the analgesic effect was "significant" or "moderate" at a certain dose for three consecutive days, the patient was classified as a "responder" and was considered to have "completed" the study. RESULTS:A fentanyl citrate patch was administered to 208 of 209 enrolled patients. In the full-analysis set, 87.0% of the patients were "responders" (95% confidence interval 81.7-91.3%). In 148 patients, the optimum dose was low (0.5 mg in 99, and 1 mg in 49), with patients finishing the study on days 4-8. Following dose escalation to 4 mg, respiratory depression occurred in one patient; however, this was considered a mild adverse event. CONCLUSION:A low-dose fentanyl citrate patch was effective in the management of cancer pain in opioid-naïve patients and was well tolerated. STUDY REGISTRATION:JPRN-JapicCTI-173717.
journal_name
Clin Drug Investigjournal_title
Clinical drug investigationauthors
Yamaguchi S,Uchida E,Terahara T,Okawa K,Hashimoto F,Tanaka Ydoi
10.1007/s40261-020-00965-9subject
Has Abstractpub_date
2020-11-01 00:00:00pages
1041-1052issue
11eissn
1173-2563issn
1179-1918pii
10.1007/s40261-020-00965-9journal_volume
40pub_type
临床试验,杂志文章abstract:BACKGROUND AND OBJECTIVE: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 vasospas...
journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章
doi:10.2165/00044011-200727120-00004
更新日期:2007-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:The optimal choice for first- and second-line antiseizure medications for pediatric patients with convulsive status epilepticus remains ambiguous. The present study aimed to estimate the comparative effect on the efficacy and safety of different antiseizure medications in pediatric patients wit...
journal_title:Clinical drug investigation
pub_type:
doi:10.1007/s40261-020-00975-7
更新日期:2021-01-01 00:00:00
abstract:OBJECTIVE:To characterise the pharmacokinetics of indinavir during different phases of the menstrual cycle in HIV-infected women. DESIGN:Open-label study. SETTING:The immunodeficiency clinic at Erie County Medical Center, Buffalo, New York. PATIENTS:Ten HIV-infected women were enrolled in the study. Eligibility crit...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200222020-00007
更新日期:2002-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Clinicians must choose between an increasing number of medications for the treatment of pulmonary arterial hypertension (PAH) with different routes of administration, adverse effects, costs and efficacies. We constructed a decision analysis to help inform treatment choices in PAH. METHODS:We c...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/11317820-000000000-00000
更新日期:2009-01-01 00:00:00
abstract:BACKGROUND:Multimodal pain therapy including cyclo-oxygenase-2 inhibitors can result in optimal pain management with decreased opioid use and fewer opioid-related adverse events. Patient reported outcomes (PROs) help identify benefits in reduced opioid use and increased pain control. METHODS:In this randomized, double...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/11317570-000000000-00000
更新日期:2009-01-01 00:00:00
abstract::Pantoprazole is a proton pump inhibitor (PPI) that binds irreversibly and specifically to the proton pump, thereby reducing gastric acid secretion. Pantoprazole has a relatively long duration of action compared with other PPIs, and a lower propensity to become activated in slightly acidic body compartments. To date, n...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.2165/1153121-S0-000000000-00000
更新日期:2009-01-01 00:00:00
abstract::Recurrent aphthous ulcer (RAU) is the most prevalent oral mucosal disease in humans, estimated to affect between 5% and 50% of the general population. The minor manifestation of the condition is the most common and is characterised by small, shallow, round or oval lesions that are surrounded by a raised erythematous h...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200525090-00001
更新日期:2005-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:As a β-adrenoceptor antagonist (β-blocker), esmolol can reduce cardiac output and the phosphodiesterase III inhibitor milrinone has been shown to improve heart contractility in patients with septic shock. This study was performed to assess the effects of esmolol combined with milrinone in patie...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-015-0325-3
更新日期:2015-11-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:A novel tiotropium bromide monodose capsule dry powder inhaler (DPI) formulation and device have been developed. The formulation was based on a spray-dried matrix that enhances the aerosolizaton properties, allowing a less active tiotropium metered dose (13 µg/capsule) while maintaining the sam...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-016-0441-8
更新日期:2016-09-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Schizophrenia treatment has been shifting to resocialization by efficacious antipsychotic drugs. However, even some of the pivotal studies of approved new antipsychotic drugs with proven efficacy had failed due to high placebo response. The aim of this study was to identify the potential factor...
journal_title:Clinical drug investigation
pub_type: 杂志文章,meta分析
doi:10.1007/s40261-018-0661-1
更新日期:2018-08-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Hypertension, one of the major treatable cardiovascular (CV) risk factors, usually occurs in association with other major risk factors. As well as providing rapid blood pressure (BP) goal attainment, antihypertensive therapy should also provide reductions in CV events and mortality in a wide r...
journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章,多中心研究
doi:10.2165/00044011-200828110-00001
更新日期:2008-01-01 00:00:00
abstract:OBJECTIVE:To compare the bioavailability of two 15mg ambroxol lozenges with a commercial 30mg ambroxol tablet. DESIGN:Open-label, two-way crossover study. METHOD:Each formulation was randomly administered to 20 healthy Thai volunteers (ten male and ten female) with a 1-week washout period between formulations. After ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200323040-00007
更新日期:2003-01-01 00:00:00
abstract:BACKGROUND:Epidemiological studies and clinical trials have shown that prevention of cardiovascular disease, the ultimate goal of hypertension treatment, requires a sufficient reduction in blood pressure. OBJECTIVE:The primary objective of this study was to compare the mean decrease in systolic (SBP) and diastolic (DB...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/11531770-000000000-00000
更新日期:2010-01-01 00:00:00
abstract::Hormonal contraceptives are used worldwide by more than 100 million women. Some studies have been published about the possible appearance of depressive symptoms when using hormonal contraceptives, but this link is still a matter of debate. The purpose of this review is to provide an update of the literature on this is...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.1007/s40261-020-00966-8
更新日期:2020-12-01 00:00:00
abstract:OBJECTIVE:This study aimed to compare the systemic bioavailability of two aciclovir tablets, Rouz-Aciclovir (test) and Zovirax (reference), in 12 healthy volunteers. METHODS:In a crossover design, each subject received a single oral dose of aciclovir 400 mg followed by a 7-day washout period. Plasma concentrations of ...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/00044011-200828010-00006
更新日期:2008-01-01 00:00:00
abstract:OBJECTIVE:The aim of this study was to confirm randomized clinical trial results showing that a fixed timolol/travoprost combination (TT; DuoTrav) controls intraocular pressure (IOP) better than a fixed timolol/latanoprost combination (TL; Xalacom) in everyday ophthalmic practice, when measured in the morning and >24 h...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/0044011-200828120-00004
更新日期:2008-01-01 00:00:00
abstract:OBJECTIVE:To compare changes in lipid levels (total cholesterol [total-C], low-density lipoprotein cholesterol [LDL-C], triglycerides [TG], and high-density lipoprotein cholesterol [HDL-C]) for patients who switched from standard fenofibrate 160 mg (requiring dosing with food) to fenofibrate 145 mg with no food effect ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200828100-00002
更新日期:2008-01-01 00:00:00
abstract::HMG-CoA reductase inhibitors (statins) are highly effective drugs for prevention of cardiovascular events in high-risk patients. Due to the widespread prescription of these agents, special attention should be given to their rare adverse effects when these may have severe outcomes. Here, we report two cases of localize...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/11535470-000000000-00000
更新日期:2010-01-01 00:00:00
abstract:BACKGROUND:Cutaneous warts are caused by human papilloma virus (HPV) infection. FIT039, a specific inhibitor of CDK9, suppresses the proliferation of DNA viruses in vitro. PURPOSE:We evaluated the safety, plasma concentrations, and efficacy of FIT039 delivered by single application of an adhesive skin patch on normal ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-018-0712-7
更新日期:2019-01-01 00:00:00
abstract::Elbasvir/grazoprevir demonstrated high sustained virologic response rates 12 weeks after the end of treatment (SVR12) across five clinical trials in subjects infected with chronic hepatitis C virus (HCV) genotype 1, including those with advanced chronic kidney disease (CKD), and GT4. Despite favorable results overall,...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-017-0492-5
更新日期:2017-04-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Inhaled corticosteroid (ICS)/long-acting beta(2)-agonist (LABA) combinations are the preferred maintenance therapy for adult asthma patients uncontrolled by ICS alone. Supporting data are largely from mixed populations of adolescents and adults, although ICS/LABA combinations are not approved f...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/11533420-000000000-00000
更新日期:2010-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:TZP-101 is a selective, small molecule ghrelin receptor agonist in clinical development for the treatment of gastric motility disorders. The objectives of this study was to assess pharmacokinetic parameters of TZP-101 after multiple- and single-dose administration to healthy subjects and patien...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/00044011-200929060-00004
更新日期:2009-01-01 00:00:00
abstract:BACKGROUND:Combining two standard-of-care medications for Alzheimer's disease (AD) into a single once-daily dosage unit may improve treatment adherence, facilitate drug administration, and reduce caregiver burden. A new fixed-dose combination (FDC) capsule containing 28 mg memantine extended release (ER) and 10 mg done...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-015-0296-4
更新日期:2015-07-01 00:00:00
abstract::Opioids are the most powerful analgesic drugs currently available and consequently form an essential part of the treatment options for malignant and non-malignant chronic pain. However, the benefits of these medications can be offset by gastrointestinal adverse events such as nausea, vomiting and constipation, as well...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.1007/BF03256935
更新日期:2011-01-01 00:00:00
abstract:OBJECTIVE:The objective of this study was to evaluate the long-term cost effectiveness of exenatide once weekly (ExQW) versus insulin glargine (IG) or liraglutide 1.2 mg (Lira1.2mg) for the treatment of adult patients with type 2 diabetes mellitus (T2DM) not adequately controlled on oral antidiabetic drug (OAD) therapy...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-017-0586-0
更新日期:2018-01-01 00:00:00
abstract:INTRODUCTION:The management of advanced gastrointestinal stromal tumors (GISTs) has been modified considerably by the availability of costly tyrosine kinase inhibitors (TKIs); however, the best therapeutic sequence in terms of cost and effectiveness remains unknown. OBJECTIVE:The aim of this study was to compare four ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-016-0463-2
更新日期:2017-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:This study was performed in healthy Chinese subjects to evaluate the safety and pharmacokinetic/pharmacodynamic characteristics of a novel injection formulation of dexlansoprazole in the context of single and multiple administration, compared with the original lansoprazole injection. METHODS:H...
journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章
doi:10.1007/s40261-019-00824-2
更新日期:2019-10-01 00:00:00
abstract:OBJECTIVE:To compare the efficacy and safety of single doses of quinfamide and secnidazole in the treatment of amoebic non-dysenteric colitis in children. DESIGN:This was a prospective, longitudinal, double-blind, randomised, comparative study. SETTING:The participants were students or relatives of students at two ur...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200020020-00003
更新日期:2000-01-01 00:00:00
abstract:OBJECTIVES:This study investigated the pharmacokinetics and pharmacodynamics of a fixed-dose combination (FDC) tablet of olmesartan medoxomil 20 mg and amlodipine 5 mg (CS-8663) in healthy Chinese subjects. METHODS:This single-centre, open-label study was conducted in five healthy males and five females aged 18-45 yea...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-012-0026-0
更新日期:2012-12-01 00:00:00
abstract:BACKGROUND:Although some evidence suggests that women may be at greater risk for hypoglycemia, no conclusion has been reached, and female sex has not been taken into account in antidiabetic drug-induced hypoglycemia. This study aimed to determine whether females are at a higher risk of sulfonylurea (SU)-associated hypo...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-015-0314-6
更新日期:2015-09-01 00:00:00