Phase III Study Comparing Zegerid® With Losec® for the Relief of Heartburn Associated With Gastroesophageal Reflux Disease
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®).
Timeline
- Start
- 2011-04
- Primary completion
- 2011-10
- Completion
- 2011-10
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Zegerid Group vs Losec Group; p = 0.563; Hazard Ratio (HR) 1.097; Regression, Cox NCT01493089 ↗
paper Superiority of Zegerid over Losec for rapid heartburn relief was not demonstrated; both treatments were equally effective however the rapid onset of action of Losec was unexpected. PMID 25706883 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Omeprazole | Other / unclassified | 20 mg | — |
| Subject | sodium bicarbonate | Diagnostic / imaging agent | — | — |