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

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: Esomeprazole; Other: Placebo; Drug: PF-00885706

Study type: Interventional

Funder types: Industry

Identifiers

NCT00730665

A8311003

Details and patient eligibility

About

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.

Enrollment: 81 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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81 participants in 5 patient groups, including a placebo group

100ug

Experimental group

Treatment:

Drug: PF-00885706

Drug: Esomeprazole

Drug: Esomeprazole

Drug: Esomeprazole

Drug: Esomeprazole

Drug: Esomeprazole

Drug: PF-00885706

Drug: PF-00885706

Drug: PF-00885706

300ug

Experimental group

Treatment:

Drug: PF-00885706

Drug: Esomeprazole

Drug: Esomeprazole

Drug: Esomeprazole

Drug: Esomeprazole

Drug: Esomeprazole

Drug: PF-00885706

Drug: PF-00885706

Drug: PF-00885706

1mg

Experimental group

Treatment:

Drug: PF-00885706

Drug: Esomeprazole

Drug: Esomeprazole

Drug: Esomeprazole

Drug: Esomeprazole

Drug: Esomeprazole

Drug: PF-00885706

Drug: PF-00885706

Drug: PF-00885706

3mg

Experimental group

Treatment:

Drug: PF-00885706

Drug: Esomeprazole

Drug: Esomeprazole

Drug: Esomeprazole

Drug: Esomeprazole

Drug: Esomeprazole

Drug: PF-00885706

Drug: PF-00885706

Drug: PF-00885706

Placebo

Placebo Comparator group

Treatment:

Drug: Esomeprazole

Drug: Esomeprazole

Other: Placebo

Drug: Esomeprazole

Drug: Esomeprazole

Drug: Esomeprazole