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

Phase 2

Terminated

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Drug: PF-00885706; Other: Placebo; Drug: Esomeprazole

• Registration Number: NCT00730665
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-08-06
• Study First Submitted QC: 2008-08-07
• Study First Posted: 2008-08-08
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Disposition First Submitted: 2011-06-07
• Status Verified: 2011-07
• Disposition First Submitted QC: 2011-07-12
• Last Update Submitted: 2011-07-12
• Disposition First Posted: 2011-07-14
• Last Update Posted: 2011-07-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 81

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
100ug	PF-00885706	-
300ug	PF-00885706	-
1mg	PF-00885706	-
Placebo	Placebo	-
Placebo	Esomeprazole	-
3mg	PF-00885706	-
100ug	Esomeprazole	-
300ug	Esomeprazole	-
1mg	Esomeprazole	-
3mg	Esomeprazole	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Number of days with heartburn (daytime and night-time)	28 days
Number of days with regurgitation (daytime and night-time)	28 days
Number of heartburn and regurgitation-free days (24hrs)	28 days
Composite score of heartburn and regurgitation frequency and severity	28 days
Time to resolution of symptoms of heartburn/regurgitation	28 days
Number of antacid rescue medication (Gaviscon) tablets used	28 days
Severity of additional GERD symptoms	28 days
Quality of Life (assessed using PAGI-QOL to PGIC (Patient Global Impression of Change)	28 days
Complete resolution of heartburn	28 days
Complete resolution of regurgitation	28 days
Average severity of heartburn (daytime and night-time)	28 days
Average severity of regurgitation (daytime and night-time)	28 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇪🇸 Sevilla, Spain