NCT01493089

Phase III Study Comparing Zegerid® With Losec® for the Relief of Heartburn Associated With Gastroesophageal Reflux Disease

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: Norgine · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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®).

Conditions

• Gastroesophageal Reflux

Interventions

Type	Name	Description
DRUG	Zegerid	20 mg Zegerid suspension to be taken when heartburn occurs. Maximum one dose per day on 3 out of 14 days.
DRUG	Losec	20 mg Losec capsule to be taken when heartburn occurs. Maximum one dose per day on 3 out of 14 days.

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2011-12-15
• Last updated: 2013-08-13
• Results posted: 2013-08-13

Locations

1 site across 1 country: Poland