Phase III Study Comparing Zegerid® With Losec® for the Relief of Heartburn Associated With Gastroesophageal Reflux Disease
Status:
Completed
Trial end date:
2011-10-01
Target enrollment:
Participant gender:
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®).
Phase:
Phase 3
Details
Lead Sponsor:
Norgine
Treatments:
Omeprazole Omeprazole, sodium bicarbonate drug combination