At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Multi-centre, Double-blind, Double-dummy, Randomised, Study to Assess the Superiority of Zegerid® 20 mg vs. Losec® 20 mg in the Rapid Relief of Heartburn Associated With GERD as on Demand Therapy
In Brief
A Phase 3 clinical trial evaluating Zegerid and Losec for Gastroesophageal Reflux. Completed, enrolled 239 participants across 1 site.
Detailed Summary
Heartburn is the main symptom of Gastroesophageal Reflux Disease (GERD), which, accompanied by acid regurgitation and other symptoms, has a substantial negative impact on a patients' quality of life. Although a number of treatment options are available, a more effective therapy is still required. The failure of proton pump inhibitors (PPIs) to completely resolve symptoms is an accepted problem, with approximately 25% of patients with GERD continuing to experience the symptoms of heartburn in spite of treatment. This study aims to demonstrate an earlier onset to relief of symptoms in patients suffering from heartburn associated with GERD using an immediate-release omeprazole/sodium bicarbonate formulation when compared with delayed-release omeprazole (Losec®).
Study Details
Timeline
Interventions
20 mg Zegerid suspension to be taken when heartburn occurs. Maximum one dose per day on 3 out of 14 days.
20 mg Losec capsule to be taken when heartburn occurs. Maximum one dose per day on 3 out of 14 days.