OCT performed a local investigators’ meeting for a pediatric study in Russia. This is a second Investigator’s meeting for this international randomized Phase III pediatric clinical trial of a new treatment in infants with colitis.
This exciting meeting brought together up to 20 participants from Russian sites. This is a follow up meeting which aimed at providing status update of the study to the Sponsor and the study sites. OCT was responsible for
Russian sites already enrolled more than 25 patients into the study. The study is placed is Russia, Poland, USA, Germany and Sweden. Russian sites are enrolling patients much quicker than other sites around the world. Russian sites are considered top enrollers in this study. The client is very pleased with current enrollment status at the Russian sites. OCT was contracted by the client to provide rescue study services in 2011. The enrollment was ongoing since 2010, since then only 2 patients were enrolled by the other CRO.
Infant colic is a functional gastrointestinal disorders which affects up to the 30% of the infant population; it is primarily characterized by excessive inconsolable crying starting without any apparent cause and lasting for several hours per day.
Current non pharmacological interventions (e.g. message, restriction in maternal diet in breast-feeding infants) and pharmacological treatments (simethicone, antimuscarinic drugs) are largely unsatisfactory.
This phase IIa study is designed to evaluate the efficacy of new pediatric oral solution given once daily at two doses in comparison to placebo.
OCT is very experienced in pediatric studies in Russia, Ukraine, Belarus, Baltic States (Latvia, Lithuania and Estonia) and Bulgaria. OCT is your reliable CRO partner.
Please contact us at firstname.lastname@example.org, if you are interested in OCT pediatric experience.