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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:
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
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, see Learn About Clinical Studies.

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
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Esomeprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014