Overview

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

Status:
Terminated

Trial end date:
2008-10-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Pfizer

Treatments:

Esomeprazole
Proton Pump Inhibitors

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.