Conditions: Gastroesophageal Reflux Disease
Keywords: GERD Gastroesophageal reflux disease SPD557 Proton pump inhibitors
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 67
Healthy volunteers: no

Brief summary:
The purpose of this trial is to investigate the pharmacodynamic effect on reflux parameters of SPD557 tablets (0.5 mg t.i.d., on top of PPI treatment) in patients with Gastroesophageal Reflux Disease (GERD) with persistent symptoms despite taking a stable dose of proton pump inhibitors. Additionally the effect on symptoms will be explored and safety and tolerability will be evaluated.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: SPD557 intervention 2: placebo
Intervention descriptions: intervention 1: 0.5 mg tablet t.i.d. for 4 weeks on top of stable PPI treatment intervention 2: matching placebo tablet t.i.d. for 4 weeks on top of stable PPI treatment

Protocol document: