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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:
ClinicalTrials.gov Identifier:
NCT00730665
First Posted: August 8, 2008
Last Update Posted: July 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 ]

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00730665


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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00730665     History of Changes
Other Study ID Numbers: A8311003
First Submitted: August 6, 2008
First Posted: August 8, 2008
Last Update Posted: July 14, 2011
Last Verified: July 2011

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
Esomeprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action