[Industry Voice #20] Roche Pharma on…
Case Study: How to enroll 612 patients…
Germany-based pharmaceutical company, which has been developing products and forms of therapy in gastroenterology and hepatology, as well as the fields themselves, has contracted OCT Clinical to run a Ph3 gastroenterology study. The clinical trial will take place in Europe and Canada.
This is a double-blind, double-dummy, randomized, parallel-group, non-inferiority phase III trial on the efficacy and tolerability of 2 mg once daily vs. 1 mg twice daily budesonide orodispersible tablets for induction of histological remission in adults with eosinophilic esophagitis.
The recruitment target for the entire global study in all countries is 242 randomized male or female patients, between 18 and 75 years of age with active eosinophilic esophagitis.The plan is to involve approximately 35 sites in several European countries, with Canada as a further option.
Within this project, the OCT Clinical team is responsible for activities at four research sites in Eastern Europe. For more information on OCT’s CRO services, visit www.oct-clinicaltrials.com/services.