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NCT00730665 Clinical Trial

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

Gastroesophageal Reflux Disease Clinical Trial

Official title:
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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00730665
Other study ID # A8311003
Secondary ID
Status Terminated
Phase Phase 2
First received August 6, 2008
Last updated July 12, 2011
Start date January 2008
Est. completion date October 2008

Study information
Verified date July 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 81
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• 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.
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.

Locations
Country Name City State
Belgium Pfizer Investigational Site Bruxelles
Brazil Pfizer Investigational Site Campinas SP
Brazil Pfizer Investigational Site Porto Alegre RS
Brazil Pfizer Investigational Site Salvador BA
Brazil Pfizer Investigational Site Sao Paulo SP
France Pfizer Investigational Site Bordeaux cedex
France Pfizer Investigational Site Laval
France Pfizer Investigational Site Lyon CEDEX 03
France Pfizer Investigational Site Marseille
France Pfizer Investigational Site Nantes CEDEX 1
France Pfizer Investigational Site Nice Cedex 3
France Pfizer Investigational Site Rennes
France Pfizer Investigational Site Segre
France Pfizer Investigational Site Tours cedex 9
Germany 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 Muenchen
Germany Pfizer Investigational Site Muenster
Korea, Republic of Pfizer Investigational Site Seoul
Korea, Republic of Pfizer Investigational Site Seoul
Korea, Republic of Pfizer Investigational Site Seoul
Korea, Republic of Pfizer Investigational Site Seoul
Korea, Republic of Pfizer Investigational Site Seoul
Slovakia Pfizer Investigational Site Bratislava
Slovakia Pfizer Investigational Site Bratislava
Slovakia Pfizer Investigational Site Bratislava
Slovakia Pfizer Investigational Site Trnava
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site Sevilla

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

Belgium,  Brazil,  France,  Germany,  Korea, Republic of,  Slovakia,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Number of days with heartburn (daytime and night-time) 28 days No
Secondary Number of days with regurgitation (daytime and night-time) 28 days No
Secondary Number of heartburn and regurgitation-free days (24hrs) 28 days No
Secondary Composite score of heartburn and regurgitation frequency and severity 28 days No
Secondary Time to resolution of symptoms of heartburn/regurgitation 28 days No
Secondary Number of antacid rescue medication (Gaviscon) tablets used 28 days No
Secondary Severity of additional GERD symptoms 28 days No
Secondary Quality of Life (assessed using PAGI-QOL to PGIC (Patient Global Impression of Change) 28 days No
Secondary Complete resolution of heartburn 28 days No
Secondary Complete resolution of regurgitation 28 days No
Secondary Average severity of heartburn (daytime and night-time) 28 days No
Secondary Average severity of regurgitation (daytime and night-time) 28 days No
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Completed NCT00625495 - Study Comparing the Effects of Esomeprazole Adminstered Orally and Intravenously on Basal and Pentrigastrin-stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD) Phase 4
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