Efficacy And Safety Of PF-00885706 For The Relief Of Symptoms In Subjects With Gastro-esophageal Reflux Disease (GERD)
NCT ID: NCT00730665
Last Updated: 2011-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
81 participants
INTERVENTIONAL
2008-01-31
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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100ug
PF-00885706
Capsule, 100ug, every 12 hours (twice a day)
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.
300ug
PF-00885706
Capsule, 300ug, every 12 hours (twice a day)
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.
1mg
PF-00885706
Capsule, 1mg, every 12 hours (twice a day)
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.
3mg
PF-00885706
Capsule, 3mg, every 12 hours (twice a day)
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.
Placebo
Placebo
Capsule, Placebo, every 12 hours (twice a day)
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.
Interventions
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PF-00885706
Capsule, 100ug, every 12 hours (twice a day)
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.
PF-00885706
Capsule, 300ug, every 12 hours (twice a day)
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.
PF-00885706
Capsule, 1mg, every 12 hours (twice a day)
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.
PF-00885706
Capsule, 3mg, every 12 hours (twice a day)
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.
Placebo
Capsule, Placebo, every 12 hours (twice a day)
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.
Eligibility Criteria
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Inclusion 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 any esophageal or gastric diseases/conditions that may contribute to their GERD symptoms.
* If female; pregnant, lactating or positive serum or urine pregnancy tests.
18 Years
65 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
Pfizer Investigational Site
Nantes, , France
Pfizer Investigational Site
Rennes, , France
Pfizer Investigational Site
Segré, , France
Pfizer Investigational Site
Tours, , France
Pfizer Investigational Site
Amberg, , Germany
Pfizer Investigational Site
Berlin, , Germany
Pfizer Investigational Site
Eisenach, , Germany
Pfizer Investigational Site
Freising, , Germany
Pfizer Investigational Site
Hamburg, , Germany
Pfizer Investigational Site
Karlsruhe, , Germany
Pfizer Investigational Site
Koenigslutter, , Germany
Pfizer Investigational Site
Konstanz, , Germany
Pfizer Investigational Site
Leipzig, , Germany
Pfizer Investigational Site
Madgeburg, , Germany
Pfizer Investigational Site
Mannheim, , Germany
Pfizer Investigational Site
München, , Germany
Pfizer Investigational Site
Münster, , Germany
Pfizer Investigational Site
Bratislava, , Slovakia
Pfizer Investigational Site
Bratislava, , Slovakia
Pfizer Investigational Site
Bratislava, , Slovakia
Pfizer Investigational Site
Trnava, , Slovakia
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Barcelona, Barcelona, Spain
Pfizer Investigational Site
Seville, Sevilla, Spain
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A8311003
Identifier Type: -
Identifier Source: org_study_id
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