Clinical trial NCT00730665: Efficacy And Safety Of PF-00885706 For The Relief Of Symptoms In Subjects With Gastro-esophageal Reflux Disease (GERD)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Gastroesophageal Reflux Disease
Keywords: PPI partial responders with non-erosive GERD.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-08-08
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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 proton pump inhibitor \[PPI\] treatment), in subjects with gastro-esophageal reflux (GERD) who have inadequate relief with PPIs.


Eligibility 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.

Primary outcomes:
measure: 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)]
timeFrame: 28 days
Secondary outcomes:
measure: Number of days with heartburn (daytime and night-time)
timeFrame: 28 days
measure: Number of days with regurgitation (daytime and night-time)
timeFrame: 28 days
measure: Number of heartburn and regurgitation-free days (24hrs)
timeFrame: 28 days
measure: Composite score of heartburn and regurgitation frequency and severity
timeFrame: 28 days
measure: Time to resolution of symptoms of heartburn/regurgitation
timeFrame: 28 days
measure: Number of antacid rescue medication (Gaviscon) tablets used
timeFrame: 28 days
measure: Severity of additional GERD symptoms
timeFrame: 28 days
measure: Quality of Life (assessed using PAGI-QOL to PGIC (Patient Global Impression of Change)
timeFrame: 28 days
measure: Complete resolution of heartburn
timeFrame: 28 days
measure: Complete resolution of regurgitation
timeFrame: 28 days
measure: Average severity of heartburn (daytime and night-time)
timeFrame: 28 days
measure: Average severity of regurgitation (daytime and night-time)
timeFrame: 28 days
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Salvador
country: Brazil
facility: Pfizer Investigational Site
state: BA
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: Campinas
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Nice
country: France
facility: Pfizer Investigational Site
state: Cedex 3
city: Bordeaux cedex
country: France
facility: Pfizer Investigational Site
city: Laval
country: France
facility: Pfizer Investigational Site
city: Lyon CEDEX 03
country: France
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
city: Nantes CEDEX 1
country: France
facility: Pfizer Investigational Site
city: Rennes
country: France
facility: Pfizer Investigational Site
city: Segre
country: France
facility: Pfizer Investigational Site
city: Tours cedex 9
country: France
facility: Pfizer Investigational Site
city: Amberg
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Eisenach
country: Germany
facility: Pfizer Investigational Site
city: Freising
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Karlsruhe
country: Germany
facility: Pfizer Investigational Site
city: Koenigslutter
country: Germany
facility: Pfizer Investigational Site
city: Konstanz
country: Germany
facility: Pfizer Investigational Site
city: Leipzig
country: Germany
facility: Pfizer Investigational Site
city: Madgeburg
country: Germany
facility: Pfizer Investigational Site
city: Mannheim
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Muenster
country: Germany
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Trnava
country: Slovakia
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: