Infantile colic can be very stressful on parents who cannot console their children during a crying episode. Infant Colic is often defined by the “rule of three”, which is first when the infant cries for more than 3 hours a day, second when the infant cries more than 3 days per week, and third when the infant cries for longer than three weeks in an infant who is well-fed and otherwise healthy. Since there no possible way to communicate with the infant or to assess the reason for their colic, the only purpose a medical physician can serve is to check if there is an organic or physical problem with the infant, offer some kind of possible treatment, and provide some support for the parents of the infant. Colic is part of the normal development of any infant in the first 3 months of their young life, on average an infant might cry a total of 2.2 hours a day and this will peak at 6 week of age and then gradually decrease as they get older.
OCT is very pleased to announce the progress of the pediatric clinical study which is a global double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy and safety of the oral administration of this study drug in infant colic. When this clinical study was initially launched 5 investigational sites in Russia were opened, at that point this study was also being run in Sweden, Poland, Germany, and USA. Currently OCT has 35 randomized patients in Russia, and the total amount of patients in the other countries is 2. The Sponsor was very concerned with the recruitment rate of the other countries involved in the study that is why they requested that OCT take on the task of potentially rescuing these other sites by opening additional sites in Russia. OCT also initiated two more sites in Russia to improve the recruitment projections. The infant patient age range for this study is between 1 and 4 months.
OCT has had previous experience in pediatric clinical studies. Patient recruitment can sometimes take longer than speculated because the population from which the patients are being selected is very finite. OCT is very committed to this project with their aggressive approach opening addition sites and recruiting more patients for the clinical study. Satisfying the Sponsor and completing the clinical trial within the projected timeframe is always OCT priority. Hopefully in the future OCT will be able to have more reoccurring business from this Sponsor.