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Group Trials (group + trials)

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Medical Sciences100%

Terms modified by Group Trials

  • group trials register
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    Selected Abstracts

    Venous thromboembolism and nonsmall cell lung cancer

    CANCER, Issue 23 2009
    A pooled analysis of National Cancer Institute of Canada Clinical Trials Group trials
    Abstract BACKGROUND: Advanced nonsmall cell lung cancer (NSCLC) is associated with venous thromboembolism (VTE). However, to the authors' knowledge, the incidence of VTE in early NSCLC, predictors of VTE, and the prognostic significance of VTE in NSCLC have not been explored. METHODS: Individual patient data from 3 National Cancer Institute of Canada Clinical Trials Group trials were analyzed (n = 1987 patients). Clinical Trial BR.10 was a randomized study of postoperative vinorelbine and cisplatin versus observation in patients with stage IB/II NSCLC (grading determined according to the TNM staging system). Clinical Trial BR.18 was a randomized study of paclitaxel and carboplatin with or without the metalloproteinase inhibitor BMS-275291 in patients with advanced NSCLC. BR.21 was a randomized study of erlotinib versus placebo in patients with previously treated NSCLC. The relations between VTE, treatment, concomitant medications, and patient characteristics were explored in univariate and multivariate analyses. Survival analysis was completed using Cox regression. RESULTS: The incidence of VTE ranged from 0% in patients with early stage NSCLC on the observation arm of BR.10 to 7.9% in patients with advanced NSCLC who received chemotherapy (BR.18). Patients with early stage NSCLC who received chemotherapy (BR.10) and patients with previously treated NSCLC who received erlotinib or placebo (BR.21) had a VTE incidence of ,3%. Factors that were found to be predictive of VTE included previous VTE (BR.18; P = .001) and obesity (BR.10; P = .03). In patients with advanced NSCLC, VTE was associated with shorter survival (BR.18: hazard ratio [HR], 1.61; 95% confidence interval [95% CI], 1.26-2.07 [P = .0002]; BR.21: HR, 2.18; 95% CI, 1.57-3.04 [P < .0001]). CONCLUSIONS: In patients with both early stage and advanced stage NSCLC, VTE occurred more frequently in patients who received chemotherapy (but not erlotinib or BMS-275291). In patients with advanced stage NSCLC, VTE was associated with obesity and a history of VTE. VTE was found to be prognostic in patients with advanced stage NSCLC. Cancer 2009. © 2009 American Cancer Society. [source]

    Critical review of oral drug treatments for diabetic neuropathic pain,clinical outcomes based on efficacy and safety data from placebo-controlled and direct comparative studies

    DIABETES/METABOLISM: RESEARCH AND REVIEWS, Issue 3 2005
    Hugo Adriaensen
    Abstract The present review aims to evaluate the efficacy and safety of a selection of oral treatments for the management of painful diabetic neuropathy. A literature review was conducted retrieving placebo-controlled and direct comparative studies with a selection of oral treatments for painful diabetic neuropathy. All studies were analyzed with regard to efficacy and tolerability. Efficacy was evaluated as the percentage improvement in pain intensity between baseline and endpoint. Tolerability was evaluated by means of study discontinuations due to adverse events and by incidence of drug-related adverse events. The analyzed trials enrolled different patient populations with mostly small numbers of patients. The great variability in dosages and dose titration schemes, cross-over designs with variable wash-out periods, and other design schemes made comparison between the different studies difficult. Gabapentin, lamotrigine, tramadol, oxycodone, mexiletine, and acetyl-L-carnitine were the only treatments studied in large (at least 100 patients), placebo-controlled parallel group trials. It is concluded that standardization in design and reporting for comparison of treatments is needed. Validated questionnaires for evaluation of the efficacy and safety should be further developed. Based on the reviewed randomised controlled trials, gabapentin shows good efficacy, a favourable side-effect profile with lack of drug interactions and therefore it may be a first choice treatment in painful diabetic neuropathy, especially in the elderly. However, head to head trials of current treatments are lacking and therefore randomized controlled trials are required to address this issue. Copyright © 2005 John Wiley & Sons, Ltd. [source]

    Safety and efficacy of nabumetone in osteoarthritis: emphasis on gastrointestinal safety

    ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 4 2000
    Scott
    To compare the efficacy and gastrointestinal (GI) safety of nabumetone with two comparator non-steroidal anti-inflammatory drugs (NSAIDs), diclofenac SR and piroxicam. Methods: Two randomized, double-blind, multicentre, parallel group trials were carried out in patients with moderate to severe osteoarthritis of the hip or knee. During the 6 month treatment phase, the safety and efficacy of nabumetone (1500,2000 mg/day) was compared to diclofenac SR (100 mg/day) or piroxicam (20,30 mg/day). GI safety was evaluated by reviewing all adverse events reported during the trials and presenting all cases of ulcers (complicated and uncomplicated), as well as other bleeding events that may have been associated with NSAID administration. Results: Most of the efficacy parameters showed no significant differences between the NSAIDs, although diclofenac SR was significantly better than nabumetone in one of 18 efficacy parameters. Nabumetone-treated patients experienced significantly fewer ulcer and bleeding events compared to patients treated with the comparator NSAIDs [1.1% (4/348) vs. 4.3% (15/346), P= 0.01]. Bleeding events, including outright upper or lower GI bleeding or a significant decline in haemoglobin, occurred in significantly fewer patients treated with nabumetone than with the comparator NSAIDs [1.1% (4/348) vs. 3.5% (12/346), P < 0.05]. More importantly, complications associated with either ulcers (perforation) or bleeding (leading to hospitalization or withdrawal) occurred in significantly fewer patients receiving nabumetone [0% (0/348)] than with comparator NSAIDs [1.4% (5/346), (P < 0.05)]. Conclusion: The results suggest that nabumetone was similar in efficacy by most criteria to diclofenac SR and piroxicam in relieving the symptoms of osteoarthritis; however, nabumetone's GI safety profile was generally superior to that of both comparator NSAIDs. In the pooled analysis, nabumetone was associated with a significantly lower total incidence of ulcers and bleeding events, and a significantly lower incidence of complications associated with these events. [source]

    Methods to Determine the Minimum Important Difference for a Sexual Event Diary Used by Postmenopausal Women with Hypoactive Sexual Desire Disorder

    THE JOURNAL OF SEXUAL MEDICINE, Issue 5 2007
    Tara Symonds PhD
    ABSTRACT Introduction., Recently, there has been much discussion in the literature about how to determine the meaningfulness of results generated from a patient-reported outcome measure. A number of reviews have shown that there are two main approaches: anchor- and distribution-based approaches for determining the minimum important difference (MID) for a new measure. There are issues with calculating an MID using each method: Will the two approaches give the same estimate? If the estimates differ, how do you decide on one estimate? Would asking patients directly be more beneficial? Aim., A case study was presented to address these issues based on a newly developed diary assessing number of satisfactory sexual events (SSEs) per week in women with hypoactive sexual desire disorder (HSDD). Methods., Anchor- and distribution-based estimates were generated from data gathered in two double-blind, placebo-controlled, parallel group trials for the treatment of HSDD (N = 788). A novel interview study was used to ask women directly about an MID for SSEs (N = 77). Main Outcome Measures., Defining the MID for an SSE diary in women with HSDD. Results., The estimates varied, producing a range of mean MID estimates between 0.04 and 0.46 SSEs per week. Conclusion., We recommend that rather than defining the MID, a range should be selected from the set of estimates formed by the limits of the 95% confidence intervals. Symonds T, Spino C, Sisson M, Soni P, Martin M, Gunter L, and Patrick DL. Methods to determine the minimum important difference for a sexual event diary used by postmenopausal women with hypoactive sexual desire disorder. J Sex Med 2007;4;1328,1335. [source]