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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
81
Capsule, 100ug, every 12 hours (twice a day)
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.
Capsule, 300ug, every 12 hours (twice a day)
Complete resolution of heartburn and regurgitation. [i.e. no more than one day with either mild heartburn or regurgitation over the seven days prior to the assessment time-point (Visit 6 and Visit 8)]
Time frame: 28 days
Number of days with heartburn (daytime and night-time)
Time frame: 28 days
Number of days with regurgitation (daytime and night-time)
Time frame: 28 days
Number of heartburn and regurgitation-free days (24hrs)
Time frame: 28 days
Composite score of heartburn and regurgitation frequency and severity
Time frame: 28 days
Time to resolution of symptoms of heartburn/regurgitation
Time frame: 28 days
Number of antacid rescue medication (Gaviscon) tablets used
Time frame: 28 days
Severity of additional GERD symptoms
Time frame: 28 days
Quality of Life (assessed using PAGI-QOL to PGIC (Patient Global Impression of Change)
Time frame: 28 days
Complete resolution of heartburn
Time frame: 28 days
Complete resolution of regurgitation
Time frame: 28 days
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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.
Capsule, 1mg, every 12 hours (twice a day)
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.
Capsule, 3mg, every 12 hours (twice a day)
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.
Capsule, Placebo, every 12 hours (twice a day)
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.
Pfizer Investigational Site
Brussels, Belgium
Pfizer Investigational Site
Salvador, Estado de Bahia, Brazil
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, Brazil
Pfizer Investigational Site
Campinas, São Paulo, Brazil
Pfizer Investigational Site
São Paulo, São Paulo, Brazil
Pfizer Investigational Site
Nice, Cedex 3, France
Pfizer Investigational Site
Bordeaux, France
Pfizer Investigational Site
Laval, France
Pfizer Investigational Site
Lyon, France
Pfizer Investigational Site
Marseille, France
...and 28 more locations
Average severity of heartburn (daytime and night-time)
Time frame: 28 days
Average severity of regurgitation (daytime and night-time)
Time frame: 28 days