Colima

The trial investigates the safety, effectiveness, and how the body processes vericiguat in children with heart failure caused by left ventricular systolic dysfunction. It compares vericiguat to a placebo to see if vericiguat better reduces levels of a heart failure marker called NT-proBNP over 16 weeks. This is a combined Phase 2/3 study that includes a base period and an optional long-term extension period. Participants receive vericiguat either as tablets (2.5 mg, 5 mg, or 10 mg) or oral suspension (0.2 mg/mL or 1 mg/mL) once daily, or matching placebo tablets or suspension. After the initial 16-week base period, eligible participants can join an open-label extension lasting up to approximately 8 years, continuing to receive vericiguat to further evaluate safety and long-term effects. During the study, participants undergo tests to measure NT-proBNP at baseline and Week 16. In the extension, researchers monitor for any adverse events and reasons for stopping the study drug. Throughout, participants are assessed for heart function and safety, with follow-ups continuing for up to 8 years. This allows detailed evaluation of treatment impact and safety over both short and long terms.

Researchers are investigating the effectiveness of trimebutine and probiotics in treating Functional Abdominal Pain Disorders (FAPD) in children aged 4 to 18 years. The study aims to determine whether trimebutine, probiotics, or their combination can reduce symptoms of FAPD, which includes conditions like Irritable Bowel Syndrome, Functional Dyspepsia, Abdominal Migraine, and Functional Abdominal Pain Not Otherwise Specified (FAP-NOS). This is a double-blind, placebo-controlled, randomized clinical trial following CONSORT guidelines, enrolling 82 pediatric patients meeting Rome IV criteria for FAPD. Participants will be randomly assigned to one of three groups: trimebutine combined with probiotics, probiotics with placebo, or trimebutine with placebo. Trimebutine will be given at a pediatric dose of 15 mg/kg/day divided into two daily doses for 8 weeks. Probiotics (Lactobacillus rhamnosus) will be given as a single chewable tablet at night daily for 8 weeks, and placebo tablets will match the probiotic regimen. Clinical follow-ups and evaluations will occur at baseline, 4 weeks, and 8 weeks to assess pain and symptom changes. During the study, participants will complete Rome IV Criteria Questionnaires, a Visual Analog Scale for pain, and a quality of life survey (PedsQL 4.0) at each visit. Researchers will monitor treatment adherence and remove from the study any participant who voluntarily withdraws, has less than 80% adherence, participates in another study, or receives simultaneous treatment from another physician. The primary outcome measured is the average score on the Visual Analog Scale for abdominal pain from baseline to 8 weeks post-treatment.