Gastroesophageal Reflux Disease
Conditions
Keywords
PPI partial responders with non-erosive GERD.
Brief 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.
Interventions
DRUGPF-00885706
Capsule, 100ug, every 12 hours (twice a day)
DRUGEsomeprazole
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.
OTHERPlacebo
Capsule, Placebo, every 12 hours (twice a day)
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with a diagnosis of GERD who fulfill the following criteria: who have symptoms for least six months prior to enrollment; who are currently on daily treatment with a PPI and have been on such treatment for at least 3 months; whose symptoms are persistent, troublesome and that include heartburn and/or regurgitation as their predominant symptoms despite treatment with a PPI; who are seeking relief of persistent symptoms.
Exclusion criteria
* Subjects with erosive esophagitis - An endoscopy within the last 5 years is required to verify absence. * Subjects with any esophageal or gastric diseases/conditions that may contribute to their GERD symptoms. * If female; pregnant, lactating or positive serum or urine pregnancy tests.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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)] | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Number of days with regurgitation (daytime and night-time) | 28 days |
| Number of heartburn and regurgitation-free days (24hrs) | 28 days |
| Composite score of heartburn and regurgitation frequency and severity | 28 days |
| Time to resolution of symptoms of heartburn/regurgitation | 28 days |
| Number of antacid rescue medication (Gaviscon) tablets used | 28 days |
| Number of days with heartburn (daytime and night-time) | 28 days |
| Quality of Life (assessed using PAGI-QOL to PGIC (Patient Global Impression of Change) | 28 days |
| Complete resolution of heartburn | 28 days |
| Complete resolution of regurgitation | 28 days |
| Average severity of heartburn (daytime and night-time) | 28 days |
| Average severity of regurgitation (daytime and night-time) | 28 days |
| Severity of additional GERD symptoms | 28 days |
Countries
Belgium, Brazil, France, Germany, Slovakia, South Korea, Spain
Outcome results
None listed