Control groups, clinical trials, phase

Phase IV. Studies or trials conducted after a medicine is marketed to provide additional details about the medicine s efficacy or safety profile. Different formulations, dosages, durations of treatment, medicine interactions, and other medicine comparisons may be evaluated. New age groups, races, and other types of patients can be studied. Detection and definition of previously unknown or inadequately quantified adverse reactions and related risk factors are an important aspect of many Phase IV studies. If a marketed medicine is to be evaluated for another (i.e., new) indication, then those clinical trials are considered Phase II clinical trials. The term postmarketing surveillance is frequently used to describe those clinical studies in Phase IV (i.e., the period following marketing) that are primarily observational or nonexperimental in nature, to distinguish them from well-controlled Phase IV clinical trials or marketing studies. 

As an example of potential clinical application of the proposed theoretical model, preliminary results of a phase I clinical trial are described below. We estimated the values of relaxation time and ratio Max/Max in adolescents with different results of endoscopy. We found that the mean relaxation time was significantly longer in subjects with a severe gastric and duodenal inflammation, namely, with ulcers and erosions compared to a healthy control group (p<0.05). The exhaled air of patients with milder forms of the disease and of the control group caused faster sensor relaxation after their interaction (Table 7.1). 

The promising second oral therapy is Temsirolimus (Wyeth Pharm). Temsirolimus is believed to block the proliferation of immune T cells activated by interleukin, IL-2. The phase It clinical trial of Temsirolimus was also an international double blind placebo controlled trial. The trial involved 296 patients with either RR MS or SP MS with relapses. Participants received one of three doses of oral temsirolimus or placebo daily for 9 months. The primary outcome measure was the number of enhancing lesions after 9 months in study. By 32 w eeks into the study, those in the highest treatment dose had 47.8% fewer new enhancing lesions compared to those on placebo. The high dose group also had 51 % fev er relapses than the placebo group. Side effects included mouth ulceration or inflammation, menstrual dysfunction, hyperlipidemia and rashes. 

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