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

This study has been terminated.
(This study has been placed on clinical hold by the sponsor due to operational reasons.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00730665
First received: August 6, 2008
Last updated: July 12, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Gastroesophageal Reflux Disease
Drug: PF-00885706
Drug: Esomeprazole
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 81
Study Start Date: January 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 100ug Drug: PF-00885706
Capsule, 100ug, every 12 hours (twice a day)
Drug: Esomeprazole
Patients entering the run-in phase lasting 6 weeks (42 days) will be switched from their current proton pump inhibitor (PPI) treatment and maintained on a standard background PPI - open label esomeprazole 20 mg to be taken once daily 1 hour before breakfast. Subjects meeting randomization criteria at Visit 4 are randomly assigned to one of the active arms of PF-00885706 or matching placebo, in addition to esomeprazole.
Experimental: 300ug Drug: PF-00885706
Capsule, 300ug, every 12 hours (twice a day)
Drug: Esomeprazole
Patients entering the run-in phase lasting 6 weeks (42 days) will be switched from their current proton pump inhibitor (PPI) treatment and maintained on a standard background PPI - open label esomeprazole 20 mg to be taken once daily 1 hour before breakfast. Subjects meeting randomization criteria at Visit 4 are randomly assigned to one of the active arms of PF-00885706 or matching placebo, in addition to esomeprazole.
Experimental: 1mg Drug: PF-00885706
Capsule, 1mg, every 12 hours (twice a day)
Drug: Esomeprazole
Patients entering the run-in phase lasting 6 weeks (42 days) will be switched from their current proton pump inhibitor (PPI) treatment and maintained on a standard background PPI - open label esomeprazole 20 mg to be taken once daily 1 hour before breakfast. Subjects meeting randomization criteria at Visit 4 are randomly assigned to one of the active arms of PF-00885706 or matching placebo, in addition to esomeprazole.
Experimental: 3mg Drug: PF-00885706
Capsule, 3mg, every 12 hours (twice a day)
Drug: Esomeprazole
Patients entering the run-in phase lasting 6 weeks (42 days) will be switched from their current proton pump inhibitor (PPI) treatment and maintained on a standard background PPI - open label esomeprazole 20 mg to be taken once daily 1 hour before breakfast. Subjects meeting randomization criteria at Visit 4 are randomly assigned to one of the active arms of PF-00885706 or matching placebo, in addition to esomeprazole.
Placebo Comparator: Placebo Other: Placebo
Capsule, Placebo, every 12 hours (twice a day)
Drug: Esomeprazole
Patients entering the run-in phase lasting 6 weeks (42 days) will be switched from their current proton pump inhibitor (PPI) treatment and maintained on a standard background PPI - open label esomeprazole 20 mg to be taken once daily 1 hour before breakfast. Subjects meeting randomization criteria at Visit 4 are randomly assigned to one of the active arms of PF-00885706 or matching placebo, in addition to esomeprazole.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00730665

  Show 38 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00730665     History of Changes
Other Study ID Numbers: A8311003
Study First Received: August 6, 2008
Last Updated: July 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
PPI partial responders with non-erosive GERD.

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Proton Pump Inhibitors
Omeprazole
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014