Efficacy and safety of enflicoxib for treatment of canine osteoarthritis: A 6‐week randomised, controlled, blind, multicentre clinical trial

IntroductionUnstable angina (UA), referred to as acute coronary syndrome (ACS), causes unexpected chest pain. Xueshuantong injection (lyophilised) (XST) is a traditional Chinese herbal injection having the potential to treat ACS. However, no clinical trial has been performed in this field. This clinical trial aims to examine the efficacy and safety of XST.Methods and analysisThis is a randomised, parallel-arm, controlled, double-blind and multicentre clinical trial. A total of 1200 participants with UA will be enrolled in a 1:1 ratio, with 600 patients included in the XST treatment group and 600 with 1/20th dose in the control group. The efficacy assessment and major adverse cardiovascular events will be observed, and the frequency of angina attack, angina pectoris will be examined at the start and end of the run-in period. All adverse events will be recorded, regardless of the severity, to assess the safety of XST. The baseline characteristics of patients will be summarised and compared using the t test or non-parametric statistical test. Qualitative data will be analysed using the χ2 or Fisher exact tests, Cochran–Mantel–Hasenszel test and Wilcoxon test.Ethics and disseminationThis trial has been approved by the Research Ethics Committee of The First Affiliated Hospital of Guangzhou University of Chinese Medicine, China (approval number: ZYYEC [2017] 0021). Written informed consent will be obtained from all participants. The results of this trial will be disseminated to the public through academic conferences and peer-reviewed journals.Trial registrationThis study was registered on the Chinese Clinical Trial Registry (http://www.chictr.org.cn/) with the ID ChiCTR1800015911.

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Comparison of efficacy and safety of fixed dose combination of rosuvastatin and choline fenofibrate to fixed dose combination of rosuvastatin and fenofibrate in patients of mixed dyslipidemia: A randomized, open-label, multicentre clinical trial in Indian population

Indian Journal of Endocrinology and Metabolism ◽

10.4103/ijem.ijem_321_16 ◽

2018 ◽

Vol 22 (5) ◽

pp. 627

Author(s):

Hanmant Barkate ◽

Piyush Patel ◽

Dimple Shah ◽

Falgun Vyas

Keyword(s):

Clinical Trial ◽

Indian Population ◽

Fixed Dose Combination ◽

Fixed Dose ◽

Efficacy And Safety ◽

Open Label ◽

Multicentre Clinical Trial ◽

Mixed Dyslipidemia ◽

Dose Combination

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Randomised, controlled, multinational, multicentre, clinical trial to examine whether HbA1c can improve in type one diabetes patients who continuously use the Paradigm® REAL-Time system with alarm function as compared to patients on multiple injection therapy receiving one six-day period of continuous glucose monitoring - without alarm function (Guardian® REAL-Time Clinical)

http://isrctn.org/> ◽

10.1186/isrctn22472013 ◽

2012 ◽

Author(s):

J Hermanides

Keyword(s):

Clinical Trial ◽

Real Time ◽

Continuous Glucose Monitoring ◽

Glucose Monitoring ◽

Multiple Injection ◽

Time System ◽

Real Time System ◽

Multicentre Clinical Trial ◽

Type One Diabetes ◽

Randomised Controlled

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CompLement C5 Antibodies for decreasing brain injury after aneurysmal Subarachnoid Haemorrhage (CLASH): study protocol for a randomised controlled phase II clinical trial

Trials ◽

10.1186/s13063-020-04838-6 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Inez Koopman ◽

◽

Gabriel J. E. Rinkel ◽

Mervyn D. I. Vergouwen

Keyword(s):

Clinical Trial ◽

Brain Injury ◽

Subarachnoid Haemorrhage ◽

Phase Ii ◽

Intervention Group ◽

Case Fatality ◽

Phase Ii Clinical Trial ◽

Aneurysmal Subarachnoid Haemorrhage ◽

Efficacy And Safety ◽

Randomised Controlled

Abstract Background The inflammatory response after aneurysmal subarachnoid haemorrhage (aSAH) has been associated with early brain injury, delayed cerebral ischaemia, poor functional outcome, and case fatality. In experimental SAH studies, complement C5 antibodies administered shortly after SAH reduced brain injury with approximately 40%. Complement component C5 may be a new therapeutic target to reduce brain injury and hereby improve the outcome after aSAH. We aim to investigate the pharmacodynamic efficacy and safety of eculizumab (complement C5 antibody) in patients with aSAH. Methods A randomised, controlled, open-label, phase II clinical trial with blinded outcome assessment. Eculizumab (1200 mg) is administered intravenously < 12 h, on day 3 and on day 7 after ictus. Patients in the intervention group receive prophylactic antibiotics for 4 weeks, and those with a central line or an external ventricular shunt and a positive fungal or yeast culture also receive prophylactic antifungal therapy for 4 weeks. The primary outcome is C5a concentration in the cerebrospinal fluid (CSF) on day 3 after ictus. Secondary outcomes include the occurrence of adverse events, inflammatory parameters in the blood and CSF, cerebral infarction on magnetic resonance imaging, and clinical and cognitive outcomes. We aim to evaluate 26 patients with CSF assessments, 13 in the intervention group and 13 in the comparator group. To compensate for early case fatality and inability to obtain CSF, we will include 20 patients per group. Discussion The CLASH trial is the first trial to investigate the pharmacodynamic efficacy and safety of eculizumab in the early phase after aSAH. Trial registration Netherlands Trial Register NTR6752. Registered on 27 October 2017 European Clinical Trials Database (EudraCT) 2017-004307-51

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