NCT00730665

Efficacy And Safety Of PF-00885706 For The Relief Of Symptoms In Subjects With Gastro-esophageal Reflux Disease (GERD)

A Parallel-Group, Randomized, Double-Blind, Multi-Center Dose Response Study To Evaluate The Efficacy And Safety Of PF-00885706, A 5-HT4 Receptor Partial Agonist, As Add-On Therapy To Esomeprazole For The Relief Of Symptoms In Subjects With Gastro-esophageal Reflux Disease (GERD) Who Have A Poor Response To Proton Pump Inhibitor (PPI) Treatment

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To understand the dose-response characteristics of PF-00885706 for efficacy in terms of symptomatic relief when used as add-on treatment to esomeprazole 20mg (standard proton pump inhibitor \[PPI\] treatment), in subjects with gastro-esophageal reflux (GERD) who have inadequate relief with PPIs.

Conditions

• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
DRUG	PF-00885706	Capsule, 100ug, every 12 hours (twice a day)
DRUG	Esomeprazole	Patients entering the run-in phase lasting 6 weeks (42 days) will be switched from their current proton pump inhibitor (PPI) treatment and maintained on a standard background PPI - open label esomeprazole 20 mg to be taken once daily 1 hour before breakfast. Subjects meeting randomization criteria at Visit 4 are randomly assigned to one of the active arms of PF-00885706 or matching placebo, in addition to esomeprazole.
DRUG	PF-00885706	Capsule, 300ug, every 12 hours (twice a day)
DRUG	Esomeprazole	Patients entering the run-in phase lasting 6 weeks (42 days) will be switched from their current proton pump inhibitor (PPI) treatment and maintained on a standard background PPI - open label esomeprazole 20 mg to be taken once daily 1 hour before breakfast. Subjects meeting randomization criteria at Visit 4 are randomly assigned to one of the active arms of PF-00885706 or matching placebo, in addition to esomeprazole.
DRUG	PF-00885706	Capsule, 1mg, every 12 hours (twice a day)
DRUG	Esomeprazole	Patients entering the run-in phase lasting 6 weeks (42 days) will be switched from their current proton pump inhibitor (PPI) treatment and maintained on a standard background PPI - open label esomeprazole 20 mg to be taken once daily 1 hour before breakfast. Subjects meeting randomization criteria at Visit 4 are randomly assigned to one of the active arms of PF-00885706 or matching placebo, in addition to esomeprazole.
DRUG	PF-00885706	Capsule, 3mg, every 12 hours (twice a day)
DRUG	Esomeprazole	Patients entering the run-in phase lasting 6 weeks (42 days) will be switched from their current proton pump inhibitor (PPI) treatment and maintained on a standard background PPI - open label esomeprazole 20 mg to be taken once daily 1 hour before breakfast. Subjects meeting randomization criteria at Visit 4 are randomly assigned to one of the active arms of PF-00885706 or matching placebo, in addition to esomeprazole.
OTHER	Placebo	Capsule, Placebo, every 12 hours (twice a day)
DRUG	Esomeprazole	Patients entering the run-in phase lasting 6 weeks (42 days) will be switched from their current proton pump inhibitor (PPI) treatment and maintained on a standard background PPI - open label esomeprazole 20 mg to be taken once daily 1 hour before breakfast. Subjects meeting randomization criteria at Visit 4 are randomly assigned to one of the active arms of PF-00885706 or matching placebo, in addition to esomeprazole.

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-08-08
• Last updated: 2011-07-14

Locations

38 sites across 7 countries: Belgium, Brazil, France, Germany, Slovakia, South Korea, Spain