Conditions: Gastroesophageal Reflux
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 239
Healthy volunteers: no

Brief 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®).

Detailed description:

Arms:
arm 1: Treatment of heartburn with Zegerid arm 2: Treatment of heartburn with Losec

Interventions: intervention 1: Zegerid intervention 2: Losec
Intervention descriptions: intervention 1: 20 mg Zegerid suspension to be taken when heartburn occurs. Maximum one dose per day on 3 out of 14 days. intervention 2: 20 mg Losec capsule to be taken when heartburn occurs. Maximum one dose per day on 3 out of 14 days.

Protocol document: