Partial Response to Proton Pump Inhibitors (PPI) Treatment: The Cost to Society and the Burden to the Patient - a Study in the US (REMAIN)

May 10, 2010 updated by: AstraZeneca

Partial Response to PPI Treatment: The Cost to Society and the Burden to the Patient

The purpose of this study is to describe common treatment pathways, to collect health care utilization data and to assess symptom load as well as impact of symptoms on daily life in GERD patients who are partial-responders to PPI treatment.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

552

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

  • United States
    • Alabama
      • Leeds, Alabama, United States
        • Research Site
    • Arizona
      • Pheonix, Arizona, United States
        • Research Site
      • Tucson, Arizona, United States
        • Research Site
    • California
      • Concord, California, United States
        • Research Site
      • Lancaster, California, United States
        • Research Site
      • Los Banos, California, United States
        • Research Site
      • Solana Beach, California, United States
        • Research Site
    • Delaware
      • Newark, Delaware, United States
        • Research Site
    • Florida
      • Altamonte Springs, Florida, United States
        • Research Site
      • Cocoa, Florida, United States
        • Research Site
      • Defuniak Springs, Florida, United States
        • Research Site
      • Largo, Florida, United States
        • Research Site
      • Maitland, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • Naples, Florida, United States
        • Research Site
      • Ocala, Florida, United States
        • Research Site
      • Orlando, Florida, United States
        • Research Site
      • Palm Harbor, Florida, United States
        • Research Site
      • Peonia, Florida, United States
        • Research Site
      • Tampa, Florida, United States
        • Research Site
    • Georgia
      • Columbus, Georgia, United States
        • Research Site
      • Roswell, Georgia, United States
        • Research Site
      • Royston, Georgia, United States
        • Research Site
      • Snellville, Georgia, United States
        • Research Site
    • Illinois
      • Belleville, Illinois, United States
        • Research Site
    • Indiana
      • Mishawaka, Indiana, United States
        • Research Site
    • Louisiana
      • Metaire, Louisiana, United States
        • Research Site
    • Maryland
      • Prince Frederick, Maryland, United States
        • Research Site
      • Towson, Maryland, United States
        • Research Site
    • Missouri
      • Florissant, Missouri, United States
        • Research Site
      • Jefferson City, Missouri, United States
        • Research Site
    • New Jersey
      • Atco, New Jersey, United States
        • Research Site
      • Fair Lawn, New Jersey, United States
        • Research Site
    • North Carolina
      • Cary, North Carolina, United States
        • Research Site
      • Elkin, North Carolina, United States
        • Research Site
      • New Bern, North Carolina, United States
        • Research Site
      • Stanley, North Carolina, United States
        • Research Site
      • Statesville, North Carolina, United States
        • Research Site
    • Ohio
      • Beachwood, Ohio, United States
        • Research Site
      • Dayton, Ohio, United States
        • Research Site
      • Vandalia, Ohio, United States
        • Research Site
    • Pennsylvania
      • Aliquippa, Pennsylvania, United States
        • Research Site
      • Philadelphia, Pennsylvania, United States
        • Research Site
    • Rhode Island
      • Warwick, Rhode Island, United States
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States
        • Research Site
    • Tennessee
      • Athens, Tennessee, United States
        • Research Site
    • Texas
      • Austin, Texas, United States
        • Research Site
      • Dallas, Texas, United States
        • Research Site
      • Irving, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
      • San Marcos, Texas, United States
        • Research Site
      • Southlake, Texas, United States
        • Research Site
    • Utah
      • West Jordan, Utah, United States
        • Research 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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with Gastroesophageal Reflux Disease (GERD) classified as partial responders to proton pump inhibitors (PPIs).

Description

Inclusion Criteria:

  • At least 6 month history of GERD symptoms
  • Treated with unchanged optimized PPI treatment for any GERD indication during a consecutive 4 week period
  • Remaining GERD symptoms despite optimized PPI treatment
  • Able to read and write in US English, and able to comply with study requirements

Exclusion Criteria:

  • Patients that have not experienced any GERD symptom improvement at all during PPI treatment
  • Involvement in the planning or conduct of the study
  • Involvement in any other observational study or in any clinical study at the time of this study or during the last 6 months

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

  • Observational Models: Cohort

Cohorts and Interventions

Group / Cohort
1
552 GERD patients, partial responders to PPI treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of life, productivity loss, frequency and severity of GERD symptoms, health care resource use
Time Frame: Collected at enrollment visit and at 3 and 6 month follow-up. (Health care resource use is at enrollment visit collected retrospectively 6 months)
Collected at enrollment visit and at 3 and 6 month follow-up. (Health care resource use is at enrollment visit collected retrospectively 6 months)
Utility values
Time Frame: Collected at enrollment visit and at 6 month follow-up.
Collected at enrollment visit and at 6 month follow-up.

Collaborators and Investigators

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

Sponsor

AstraZeneca

Collaborators

i3 Innovus

Investigators

  • Principal Investigator: Meg Good, i3 Innovus

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

November 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

November 20, 2008

First Submitted That Met QC Criteria

November 20, 2008

First Posted (Estimate)

November 21, 2008

Study Record Updates

Last Update Posted (Estimate)

May 11, 2010

Last Update Submitted That Met QC Criteria

May 10, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9120N00005

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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