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 PPI treatment), in subjects with gastro-esophageal reflux (GERD) who have inadequate relief with PPIs.

Condition	Intervention	Phase
Gastroesophageal Reflux Disease (GERD)	Drug: PF-00885706 Other: Placebo	Phase II

MedlinePlus related topics:

Esophagus Disorders GERD Heartburn

Drug Information available for:

Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium Serotonin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

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

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 ]

Estimated Enrollment:	450
Study Start Date:	January 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
100ug: Experimental Not Specified	Drug: PF-00885706 Capsule, 100ug, BID
300ug: Experimental Not Specified	Drug: PF-00885706 Capsule, 300ug, BID
1mg: Experimental Not Specified	Drug: PF-00885706 Capsule, 1mg, BID
3mg: Experimental Not Specified	Drug: PF-00885706 Capsule, 3mg, BID
Placebo: Placebo Comparator Not Specified	Other: Placebo Capsule, Placebo, BID

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

Contacts


Contact: Pfizer CT.gov Call Center	1-800-718-1021

Show 41 Study Locations

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A8311003
First Received:	August 6, 2008
Last Updated:	August 7, 2008
ClinicalTrials.gov Identifier:	NCT00730665
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

PPI partial responders with non-erosive GERD.

Study placed in the following topic categories:

Deglutition Disorders

Esophageal Motility Disorders

Digestive System Diseases

Esophageal disorder

Gastrointestinal Diseases

Omeprazole

Esophageal Diseases

Gastroesophageal Reflux

Serotonin

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00730665