Tolyatti

Researchers are evaluating the drug 4-MUST to understand its effectiveness, safety, and tolerability in treating patients with chronic cholecystitis and biliary dyskinesia. This study compares different doses of 4-MUST with a placebo to see how well the drug reduces upper abdominal pain and gastrointestinal symptoms. The trial is a phase 2, prospective, randomized, double-blind, placebo-controlled study designed to provide detailed insight into the drugs impact on these digestive conditions. Participants will be randomly assigned to one of four groups. One group receives 1 tablet of 4-MUST 128 mg plus 2 placebo tablets three times daily, another receives 2 tablets of 4-MUST 256 mg plus 1 placebo tablet three times daily, a third group takes 3 tablets of 4-MUST 384 mg three times daily, and the last group receives 3 placebo tablets three times daily. The treatment lasts for 29 days, with doses given three times a day, followed by assessment and monitoring. During the study, participants will undergo regular evaluations including pain measurement using a Visual Analog Scale VAS, gastrointestinal symptom rating via questionnaires, and quality of life assessments with the SF-36 questionnaire. Safety will be monitored through adverse event tracking, physical examinations, vital signs, laboratory tests, and electrocardiograms at multiple time points throughout the 29-day period and up to day 36. These thorough assessments aim to capture the drugs effects and tolerability over the course of treatment.

Researchers are studying the pharmacokinetics, safety, and long-term effectiveness of olokizumab in children and adolescents aged over 2 and under 18 years who have polyarticular juvenile idiopathic arthritis. This open-label, multicenter study aims to understand how the drug behaves in the body, its effects, and its safety over an extended period. Participants receive subcutaneous injections of olokizumab every 4 weeks, with doses of either 64 mg or 48 mg depending on body weight. The study includes a screening period up to 2 weeks, a main treatment period of 24 weeks, an extended treatment phase lasting up to week 164, and a safety follow-up lasting 22 weeks. The total participation time is about 188 weeks. During the study, participants will undergo assessments of drug concentration levels and response at various timepoints. Researchers will monitor joint activity, inflammation markers like C-reactive protein, and safety measures through laboratory tests. Outcome measures include maximum drug concentration and area under the concentration-time curve over 24 weeks. The study also tracks long-term safety and efficacy with regular evaluations throughout treatment and follow-up.