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

Purpose

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.

Condition	Intervention	Phase
Gastroesophageal Reflux Disease	Drug: PF-00885706 Drug: Esomeprazole Other: Placebo	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Esophagus Disorders GERD Heartburn

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of days with heartburn (daytime and night-time) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Number of days with regurgitation (daytime and night-time) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Number of heartburn and regurgitation-free days (24hrs) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Composite score of heartburn and regurgitation frequency and severity [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Time to resolution of symptoms of heartburn/regurgitation [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Number of antacid rescue medication (Gaviscon) tablets used [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Severity of additional GERD symptoms [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Quality of Life (assessed using PAGI-QOL to PGIC (Patient Global Impression of Change) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Complete resolution of heartburn [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Complete resolution of regurgitation [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Average severity of heartburn (daytime and night-time) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Average severity of regurgitation (daytime and night-time) [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment:	81
Study Start Date:	January 2008
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 100ug	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.
Experimental: 300ug	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.
Experimental: 1mg	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.
Experimental: 3mg	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.
Placebo Comparator: Placebo	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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730665

Show 38 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00730665 History of Changes
Other Study ID Numbers:	A8311003
Study First Received:	August 6, 2008
Last Updated:	July 12, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

PPI partial responders with non-erosive GERD.

Additional relevant MeSH terms:

Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Omeprazole

Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 13, 2013