OCT Successfully Completes Patient Enrollment in a Phase III Trial

OCT, a leading research organization, has successfully completed patient recruitment for a Phase III clinical trial in Armenia, achieving an impressive 200% of the initially planned target for a Netherlands-based pharmaceutical manufacturer. This remarkable milestone was reached in December 2024, with a total of 210 patients enrolled across four centers. 

The exceptional over-enrollment in Armenia was a strategic response to slower recruitment rates in other participating countries, specifically Malaysia and the Philippines. Recognizing the potential of the Armenian sites, the sponsor entrusted OCT with managing and expediting patient enrollment in those centers. 

This Phase III study is a randomized, open-label, multicenter, parallel-group, active-controlled trial designed to evaluate the non-inferiority efficacy of Itopride Hydrochloride 150mg extended-release tablets (administered once daily) compared to Itopride Hydrochloride 50mg film-coated tablets (administered three times daily) in subjects experiencing gastrointestinal symptoms caused by gastric dysmotility and delayed gastric emptying. The symptoms include bloating, early satiety, postprandial fullness, upper abdominal pain or discomfort, anorexia, heartburn, nausea, and vomiting, often associated with functional (non-ulcer) dyspepsia or chronic gastritis. 

The study aim was to enroll a total of 564 subjects, including adult males and/or non-pregnant, non-lactating females aged 18 years and above. The duration of participation for each subject is approximately 11 weeks, with the total study duration projected at around 21 months. 

OCT’s responsibilities in Armenia included project management, monitoring, logistics, and regulatory activities. The sponsor is now preparing for site audits. Stay tuned for further updates as this important study progresses.