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

PHASE2TerminatedINTERVENTIONAL
Enrollment

81

Participants

Timeline

Start Date

January 31, 2008

Primary Completion Date

October 31, 2008

Study Completion Date

October 31, 2008

Conditions
Gastroesophageal Reflux Disease
Interventions
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.

Trial Locations (38)

1200

Pfizer Investigational Site, Brussels

10117

Pfizer Investigational Site, Berlin

13000

Pfizer Investigational Site, Marseille

22143

Pfizer Investigational Site, Hamburg

33075

Pfizer Investigational Site, Bordeaux

35000

Pfizer Investigational Site, Rennes

37044

Pfizer Investigational Site, Tours

38154

Pfizer Investigational Site, Koenigslutter

39120

Pfizer Investigational Site, Madgeburg

41014

Pfizer Investigational Site, Seville

44093

Pfizer Investigational Site, Nantes

48159

Pfizer Investigational Site, Münster

49500

Pfizer Investigational Site, Segré

53000

Pfizer Investigational Site, Laval

68161

Pfizer Investigational Site, Mannheim

69003

Pfizer Investigational Site, Lyon

76199

Pfizer Investigational Site, Karlsruhe

78464

Pfizer Investigational Site, Konstanz

80469

Pfizer Investigational Site, München

85356

Pfizer Investigational Site, Freising

92224

Pfizer Investigational Site, Amberg

99817

Pfizer Investigational Site, Eisenach

40420-000

Pfizer Investigational Site, Salvador

90035-003

Pfizer Investigational Site, Porto Alegre

13070-040

Pfizer Investigational Site, Campinas

01244-030

Pfizer Investigational Site, São Paulo

06002

Pfizer Investigational Site, Nice

04109

Pfizer Investigational Site, Leipzig

826 06

Pfizer Investigational Site, Bratislava

833 05

Pfizer Investigational Site, Bratislava

851 05

Pfizer Investigational Site, Bratislava

917 02

Pfizer Investigational Site, Trnava

133-792

Pfizer Investigational Site, Seoul

135-710

Pfizer Investigational Site, Seoul

135-720

Pfizer Investigational Site, Seoul

137-701

Pfizer Investigational Site, Seoul

152-703

Pfizer Investigational Site, Seoul

08022

Pfizer Investigational Site, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT00730665 - Efficacy And Safety Of PF-00885706 For The Relief Of Symptoms In Subjects With Gastro-esophageal Reflux Disease (GERD) | Biotech Hunter | Biotech Hunter