Blind clinical trials INDEX

This was a multi-centre, pan-European, randomised double-blind placebo-controlled clinical trial in acute stroke to evaluate the effect of ancrod, a natural defribrinogenating agent (Hennerici et al. (2006)). The primary endpoint was based on the Barthel Index a favourable score of 95 or 100 or a return to the pre-stroke level at three months was viewed as a success. The primary method of statistical analysis was based on a logistic model including terms for treatment, age category, baseline Scandinavian Stroke Scale and centre. 

Based upon these observations and following Phase I safety studies, a Phase II randomized, double-blind, controlled clinical trial was undertaken to treat active ulcerative colitis with escalating doses of ISIS 2302. Based on an intent-to-treat analysis, 59% (13/22) of patients treated daily with 240 mg ISIS 2302 enema over six weeks achieved a positive response, as measured by Disease Activity Index (DAI)... 

Geohas J, Daly A, Juturu V, Finch M and Komorowski JR. Chromium picolinate and biotin combination reduces atherogenic index of plasma in patients with type 2 diabetes mellitus A placebo controlled, double-blinded, randomized clinical trial. Am. J. Med. Set 333 145-153 (2007). 

Moller Petrun A, Kamenik M. Bispectral index-guided induction of general anaesthesia in patients undergoing major abdominal surgery using propofol or etomidate a double-blind, randomized, clinical trial. Br J Anaesth 2013 110 388-96. 

FIGURE 5.2 Clinical outcome of patients in the double-blind, proof-of-concept trial evaluating EPO in acute stroke, (a) Barthel Index (rhEPO vs. placebo, p < 0.05). (b) Modified Rankin Scale (rhEPO vs. placebo, p < 0.07) on day 30. Dead patients received the worst possible score. Evolution of lesion size of patients in the efficacy trial of Albumin in acute stroke, ((a-1) and DWI and (a-2) FLAIR.) (Reprinted with permission from reference 50.)... 

Fluoxetine is a selective serotonin-reuptake inhibitor (SSRI) that produces a net increase in (post-synaptic motor neuron) serotonin delivery after 4-6 weeks of use. A double-blind, randomized cross-over trial compared fluoxetine to the tricyclic antidepressant agent protriptyline and placebo in 12 patients with sleep-disordered breathing [52], The group apnea-hypopnea index (AHI) improved with fluoxetine compared to placebo, but there was great variability of response and other measures of disordered sleep did not change. These potentially beneficial results in a small number of patients need to be replicated in well-designed larger studies to support a useful role in clinical practice. 

DITPA treatment improved left ventricular performance in rat and rabbit post-M I models of heart failure. In a double-blind, placebo controlled, pilot phase II clinical study in 19 patients with NYHA class II or III CHF in 2003, DITPA demonstrated a significant increase in cardiac index, as well as improvements in diastolic function, systemic vascular resistance, and cholesterol and triglyceride levels. In this study, DITPA was well tolerated, with no significant increase in heart rate or significant adverse events. Subsequently, a larger trial was initiated which, however, was discontinued in October 2006, based on a business decision by Titan. 

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