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

Tracking Information

First Received Date ^ICMJE

August 6, 2008

Last Updated Date

February 12, 2009

Start Date ^ICMJE

January 2008

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00730665 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Gastroesophageal Reflux Disease (GERD)

Intervention ^ICMJE

Drug: PF-00885706
Other: Placebo

Study Arms / Comparison Groups

Experimental: Not Specified
Placebo Comparator: Not Specified

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

October 2008

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

Administrative Information

NCT ID ^ICMJE

NCT00730665

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study ID Numbers ^ICMJE

A8311003

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP