scholarly journals Furosemide versus mannitol in Japanese patients with thoracic malignancy who received cisplatin-based chemotherapy using short hydration: study protocol for a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e029057
Author(s):  
Eriko Murakami ◽  
Hiroaki Akamatsu ◽  
Toshio Shimokawa ◽  
Kiyoko Wada ◽  
Nobuyuki Yamamoto
Keyword(s):  
Phase Ii ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Japanese Patients ◽  
Open Label ◽  
Institutional Review ◽  
Open Label Phase ◽  
Registration Number ◽  
Randomised Controlled ◽  
Thoracic Malignancies

IntroductionCisplatin (CDDP) is a key drug for various thoracic malignancies. To avoid renal toxicity of CDDP, mannitol is routinely used, but it sometimes causes phlebitis which damages patients’ quality of life. Furosemide is another widely used option for diuresis administered more quickly. To date, previous comparisons of these diuretics have lacked statistical significance owing to study design. We therefore undertake a randomised phase II comparative study of furosemide and mannitol in CDDP-based chemotherapy using short hydration.Methods and analysisThis is a two-arm, prospective, randomised, single-centre, open-label phase II study. The primary endpoint is set as the proportion of patients who experienced any grade of ‘creatinine increase’ using the Common Terminology Criteria for Adverse Events V.4.0, during the first cycle. Secondary endpoints are: the proportion of patients who experienced ≥grade 2 of creatinine increase during the first cycle, any grade and ≥grade 2 of creatinine increase after the completion of fourth cycle, and the proportion of patients with phlebitis. Enrolled in this trial will be 105 patients.Ethics and disseminationThis study was approved by the Wakayama Medical University Institutional Review Board on 30 March 2018 study (approval number: 2258). Patients have been enrolled since May 2018. As the study will complete accrual in March 2021, results will be published by 2021. This study will provide important information about the utility of furosemide compared with mannitol to protect against nephrotoxicity.Trial registration numberUMIN000031910.

scholarly journals Safety and efficacy of subcutaneous tocilizumab in systemic sclerosis: results from the open-label period of a phase II randomised controlled trial (faSScinate)

2017 ◽  
Vol 77 (2) ◽  
pp. 212-220 ◽  
Author(s):  
Dinesh Khanna ◽  
Christopher P Denton ◽  
Celia J F Lin ◽  
Jacob M van Laar ◽  
Tracy M Frech ◽  
...  
Keyword(s):  
Systemic Sclerosis ◽  
Phase Ii ◽  
Controlled Trial ◽  
Safety Data ◽  
Open Label ◽  
Double Blind ◽  
Skin Score ◽  
Open Label Extension ◽  
Registration Number ◽  
Randomised Controlled

ObjectivesAssess the efficacy and safety of tocilizumab in patients with systemic sclerosis (SSc) in a phase II study.MethodsPatients with SSc were treated for 48 weeks in an open-label extension phase of the faSScinate study with weekly 162 mg subcutaneous tocilizumab. Exploratory end points included modified Rodnan Skin Score (mRSS) and per cent predicted forced vital capacity (%pFVC) through week 96.ResultsOverall, 24/44 (55%) placebo-tocilizumab and 27/43 (63%) continuous-tocilizumab patients completed week 96. Observed mean (SD (95% CI)) change from baseline in mRSS was –3.1 (6.3 (–5.4 to –0.9)) for placebo and –5.6 (9.1 (–8.9 to–2.4)) for tocilizumab at week 48 and –9.4 (5.6 (–8.9 to –2.4)) for placebo-tocilizumab and –9.1 (8.7 (–12.5 to –5.6)) for continuous-tocilizumab at week 96. Of patients who completed week 96, any decline in %pFVC was observed for 10/24 (42% (95% CI 22% to 63%)) placebo-tocilizumab and 12/26 (46% (95% CI 27% to 67%)) continuous-tocilizumab patients in the open-label period; no patients had >10% absolute decline in %pFVC. Serious infection rates/100 patient-years (95% CI) were 10.9 (3.0 to 27.9) with placebo and 34.8 (18.0 to 60.8) with tocilizumab during the double-blind period by week 48 and 19.6 (7.2 to 42.7) with placebo-tocilizumab and 0.0 (0.0 to 12.2) with continuous-tocilizumab during the open-label period.ConclusionsSkin score improvement and FVC stabilisation in the double-blind period were observed in placebo-treated patients who transitioned to tocilizumab and were maintained in the open-label period. Safety data indicated increased serious infections in patients with SSc but no new safety signals with tocilizumab.Trial registration numberNCT01532869; Results.

scholarly journals Shunting outcomes in communicating hydrocephalus: protocol for a multicentre, open-label, randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e051127
Author(s):  
Tong Sun ◽  
Wenyao Cui ◽  
Jingguo Yang ◽  
Yikai Yuan ◽  
Xuepei Li ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Communicating Hydrocephalus ◽  
Open Label ◽  
Shunt Insertion ◽  
Institutional Review ◽  
Evans Index ◽  
Registration Number ◽  
Potential Benefits ◽  
Randomised Controlled

IntroductionVentriculoperitoneal shunt (VPS) remains the most widely used methods to treat communicating hydrocephalus. More recently, lumboperitoneal shunt (LPS) has been suggested as a reasonable option in some studies. However, there is lack of high-quality studies comparing these two techniques in order to certain the benefits and harms to use one of these two methods. The purpose of the current study is to determine the effectiveness and safety of the LPS versus the VPS in patients with communicating hydrocephalus.Methods and analysisAll eligible patients aged 18–90 years with communicating hydrocephalus will be recruited and then randomly allocated into LPS or VPS group in a ratio of 1:1. All patients will be analysed before shunt insertion, at the time of discharge, 1 month, 6 months, 12 months and 24 months postoperatively. The primary outcome measure is the rate of shunt failure at a 2-year follow-up term. The secondary outcomes include Keifer’s Hydrocephalus Scale, National Institute of Health Stroke Scale, Glasgow Outcome Scale Extended, Evans index, safety endpoints and cost-effectiveness of hospital stay.Ethics and disseminationThe study will be performed in compliance with the Declaration of Helsinki (2002) of the World Medical Association. The study was approved by Institutional Review Board of West China Hospital. All patients will be fully informed the potential benefits, potential risks and responsibilities, those who will sign the informed consents once they are included. Preliminary and final results will be published in peer-reviewed journals and presented at national and international congresses.Trial registration numberChiCTR2100043839.

scholarly journals Furosemide versus mannitol in patients who received cisplatin-based chemotherapy using short hydration: study protocol for a randomized controlled trial

2018 ◽  
Author(s):  
Eriko Murakami ◽  
Hiroaki Akamatsu ◽  
Toshio Shimokawa ◽  
Kiyoko Wada ◽  
Nobuyuki Yamamoto
Keyword(s):  
Renal Dysfunction ◽  
Phase Ii ◽  
Medical Information ◽  
Controlled Trial ◽  
University Hospital ◽  
Open Label ◽  
Open Label Phase ◽  
Secondary Endpoints ◽  
Clinical Trials Registry ◽  
Thoracic Malignancies

Abstract Background: Cisplatin (CDDP) is a key drug for various thoracic malignancies. To avoid renal toxicity of CDDP, mannitol is routinely used, but it reportedly causes phlebitis. Furosemide is another widely-used option for diuresis, but to date, it has not been assessed in comparison with mannitol. We therefore undertake a randomized phase II comparative study of furosemide and mannitol in CDDP-based chemotherapy using short hydration. Methods: This study is designed as a two-arm, prospective, randomized, single-center, open-label phase II study. The primary endpoint is set as the proportion of patients who experienced any grade renal dysfunction, defined as elevation in creatinine using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, during the first cycle. Secondary endpoints are: the proportion of patients who experienced ≥ grade 2 renal dysfunction during the first cycle, any grade and ≥ grade 2 renal dysfunction after the completion of forth cycle, and the proportion of patients who had phlebitis. A total of 105 patients will be enrolled in this trial. Discussion: The results of this study will suggest that furosemide can be better choice than mannitol regarding convenience and in reduction of phlebitis. Trial registration: University Hospital Medical Information Network Clinical Trials Registry, ID: UMIN000031910(http://www.umin.ac.jp/ctr/index.htm). Registered on 1 April 2018.

scholarly journals Open-label placebo for insomnia (OPIN): study protocol for a cohort multiple randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e044045
Author(s):  
Ben Colagiuri ◽  
Louise Sharpe ◽  
Zahava Ambarchi ◽  
Nick Glozier ◽  
Delwyn Bartlett ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Treatment Period ◽  
Controlled Trial ◽  
Severity Index ◽  
Open Label ◽  
Human Research Ethics ◽  
Sleep Parameters ◽  
Registration Number ◽  
Randomised Controlled ◽  
Insomnia Symptoms

IntroductionInsomnia is a prevalent sleep disorder that causes substantial personal and societal harm. There is evidence that placebo interventions can reduce insomnia symptoms, but this research has involved deceptively administering the placebo under the guise of a real medication (conventional placebo, CP), which has obvious ethical constraints. Open-label placebo (OLP) treatment, in which a placebo is administered with full disclosure that there are no active ingredients, has been proposed as a method of using the placebo effect ethically, but the efficacy and acceptability of OLP for insomnia is currently unknown.Methods and analysisThis study uses a cohort multiple randomised controlled trial design to compare OLP, CP and no treatment for insomnia. Two-hundred and sixty-seven participants with self-reported insomnia symptoms (Insomnia Severity Index, ISI ≥10) will be recruited into an observational study and have their sleep monitored over a 2-week period. Participants will then be randomised to one of three groups: invite to OLP, invite to CP described deceptively as a new pharmacological agent, or no invite/observational control. Those in OLP and CP accepting the invite receive identical placebos for a 2-week treatment period while sleep is monitored in all participants. The primary outcome is ISI at the end of the treatment period. Secondary outcomes include treatment uptake and clinically significant response rates, objective and subjective sleep parameters, fatigue, mood, expectancy, treatment satisfaction and side effects. Predictors of uptake and responses to OLP and CP will be explored.Ethics and disseminationThe trial has been approved by The University of Sydney Human Research Ethics Committee. Written informed consent is obtained from every participant. OLP and CP participants accepting the invite undergo an additional consent process. Results will be disseminated via peer-reviewed conference proceedings and publications.Trial registration numberACTRN12620001080910.

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