NCT01370863

An Explorative Trial to Evaluate the Pharmacodynamic Effect of SPD557 on Reflux Parameters in Refractory GERD Patients

An Explorative, Randomized, Placebo-controlled, DB, Parallel-group Trial, to Evaluate the Pharmacodynamic Effect of SPD557 on Reflux Parameters in Subjects With GERD & With Persistent Symptoms Despite Taking a Stable Dose of PPIs

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
DRUG	SPD557	0.5 mg tablet t.i.d. for 4 weeks on top of stable PPI treatment
DRUG	placebo	matching placebo tablet t.i.d. for 4 weeks on top of stable PPI treatment

Timeline

• Start date: 2010-12-02
• Primary completion: 2012-05-29
• Completion: 2012-05-29
• First posted: 2011-06-10
• Last updated: 2021-06-10
• Results posted: 2013-06-07

Locations

15 sites across 6 countries: Belgium, France, Germany, Netherlands, Switzerland, United Kingdom