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

July 12, 2011 updated by: Pfizer

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
81

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1200
        • Pfizer Investigational Site
  • Brazil
    • BA
      • Salvador, BA, Brazil, 40420-000
        • Pfizer Investigational Site
    • RS
      • Porto Alegre, RS, Brazil, 90035-003
        • Pfizer Investigational Site
    • SP
      • Campinas, SP, Brazil, 13070-040
        • Pfizer Investigational Site
      • Sao Paulo, SP, Brazil, 01244-030
        • Pfizer Investigational Site
  • France
      • Bordeaux cedex, France, 33075
        • Pfizer Investigational Site
      • Laval, France, 53000
        • Pfizer Investigational Site
      • Lyon CEDEX 03, France, 69003
        • Pfizer Investigational Site
      • Marseille, France, 13000
        • Pfizer Investigational Site
      • Nantes CEDEX 1, France, 44093
        • Pfizer Investigational Site
      • Rennes, France, 35000
        • Pfizer Investigational Site
      • Segre, France, 49500
        • Pfizer Investigational Site
      • Tours cedex 9, France, 37044
        • Pfizer Investigational Site
    • Cedex 3
      • Nice, Cedex 3, France, 06002
        • Pfizer Investigational Site
  • Germany
      • Amberg, Germany, 92224
        • Pfizer Investigational Site
      • Berlin, Germany, 10117
        • Pfizer Investigational Site
      • Eisenach, Germany, 99817
        • Pfizer Investigational Site
      • Freising, Germany, 85356
        • Pfizer Investigational Site
      • Hamburg, Germany, 22143
        • Pfizer Investigational Site
      • Karlsruhe, Germany, 76199
        • Pfizer Investigational Site
      • Koenigslutter, Germany, 38154
        • Pfizer Investigational Site
      • Konstanz, Germany, 78464
        • Pfizer Investigational Site
      • Leipzig, Germany, 04109
        • Pfizer Investigational Site
      • Madgeburg, Germany, 39120
        • Pfizer Investigational Site
      • Mannheim, Germany, 68161
        • Pfizer Investigational Site
      • Muenchen, Germany, 80469
        • Pfizer Investigational Site
      • Muenster, Germany, 48159
        • Pfizer Investigational Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 137-701
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 152-703
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 133-792
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 135-720
        • Pfizer Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 826 06
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 833 05
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 851 05
        • Pfizer Investigational Site
      • Trnava, Slovakia, 917 02
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain, 08022
        • Pfizer Investigational Site
      • Sevilla, Spain, 41014
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
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.
Other: Placebo
Capsule, Placebo, every 12 hours (twice a day)
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.
Drug: PF-00885706
Capsule, 300ug, every 12 hours (twice a day)
Drug: PF-00885706
Capsule, 1mg, every 12 hours (twice a day)
Drug: PF-00885706
Capsule, 3mg, every 12 hours (twice a day)
Experimental: 300ug
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.
Drug: PF-00885706
Capsule, 300ug, every 12 hours (twice a day)
Drug: PF-00885706
Capsule, 1mg, every 12 hours (twice a day)
Drug: PF-00885706
Capsule, 3mg, every 12 hours (twice a day)
Experimental: 1mg
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.
Drug: PF-00885706
Capsule, 300ug, every 12 hours (twice a day)
Drug: PF-00885706
Capsule, 1mg, every 12 hours (twice a day)
Drug: PF-00885706
Capsule, 3mg, every 12 hours (twice a day)
Experimental: 3mg
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.
Drug: PF-00885706
Capsule, 300ug, every 12 hours (twice a day)
Drug: PF-00885706
Capsule, 1mg, every 12 hours (twice a day)
Drug: PF-00885706
Capsule, 3mg, every 12 hours (twice a day)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of days with heartburn (daytime and night-time)
Time Frame: 28 days
28 days
Number of days with regurgitation (daytime and night-time)
Time Frame: 28 days
28 days
Number of heartburn and regurgitation-free days (24hrs)
Time Frame: 28 days
28 days
Composite score of heartburn and regurgitation frequency and severity
Time Frame: 28 days
28 days
Time to resolution of symptoms of heartburn/regurgitation
Time Frame: 28 days
28 days
Number of antacid rescue medication (Gaviscon) tablets used
Time Frame: 28 days
28 days
Severity of additional GERD symptoms
Time Frame: 28 days
28 days
Quality of Life (assessed using PAGI-QOL to PGIC (Patient Global Impression of Change)
Time Frame: 28 days
28 days
Complete resolution of heartburn
Time Frame: 28 days
28 days
Complete resolution of regurgitation
Time Frame: 28 days
28 days
Average severity of heartburn (daytime and night-time)
Time Frame: 28 days
28 days
Average severity of regurgitation (daytime and night-time)
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 6, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A8311003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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