Validation of Patient-reported Outcomes Measures for the Assessment of Gastroesophageal Reflux Disease (GERD) Symptoms (C27)

May 20, 2011 updated by: AstraZeneca

Validation of Patient-reported Outcomes Measures for the Assessment of GERD Symptoms and Their Subsequent Impact on Patients With Partial Response to Proton Pump Inhibitor (PPI) Treatment in a Two Part Multi-center Phase IIa Study Including a Four Week Randomised, Double-blind, Placebo-controlled, Parallel-group Treatment Period

This research study is being done to gather information about how to do further clinical studies using AZD3355 as an add-on treatment to proton pump inhibitors (PPI).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

478

Phase

  • 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

  • United States
    • Alabama
      • Athens, Alabama, United States
        • Research Site
    • Arizona
      • Tucson, Arizona, United States
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States
        • Research Site
      • Sherwood, Arkansas, United States
        • Research Site
    • California
      • Anaheim, California, United States
        • Research Site
      • Los Angeles, California, United States
        • Research Site
      • Monterey, California, United States
        • Research Site
      • Murrieta, California, United States
        • Research Site
      • Orange, California, United States
        • Research Site
      • San Diego, California, United States
        • Research Site
      • Torrance, California, United States
        • Research Site
    • Colorado
      • Colorado Springs, Colorado, United States
        • Research Site
      • Pueblo, Colorado, United States
        • Research Site
    • Florida
      • Boynton Beach, Florida, United States
        • Research Site
      • Deland, Florida, United States
        • Research Site
      • Hialeah, Florida, United States
        • Research Site
      • Jacksonville, Florida, United States
        • Research Site
      • Jupiter, Florida, United States
        • Research Site
      • Lauderdale Lakes, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • New Smyrna Beach, Florida, United States
        • Research Site
      • Pembroke Pines, Florida, United States
        • Research Site
      • Port Orange, Florida, United States
        • Research Site
      • Tampa, Florida, United States
        • Research Site
      • Zephyrhills, Florida, United States
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States
        • Research Site
      • Stockbridge, Georgia, United States
        • Research Site
    • Illinois
      • Chicago, Illinois, United States
        • Research Site
    • Kansas
      • Arkansas City, Kansas, United States
        • Research Site
      • Newton, Kansas, United States
        • Research Site
      • Wichita, Kansas, United States
        • Research Site
    • Kentucky
      • Madisonville, Kentucky, United States
        • Research Site
    • Louisiana
      • Monroe, Louisiana, United States
        • Research Site
      • Shreveport, Louisiana, United States
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States
        • Research Site
      • Chevy Chase, Maryland, United States
        • Research Site
      • Columbia, Maryland, United States
        • Research Site
      • Elkridge, Maryland, United States
        • Research Site
      • Hollywood, Maryland, United States
        • Research Site
    • Massachusetts
      • Brockton, Massachusetts, United States
        • Research Site
    • Michigan
      • Chesterfield, Michigan, United States
        • Research Site
    • Mississippi
      • Biloxi, Mississippi, United States
        • Research Site
      • Jackson, Mississippi, United States
        • Research Site
    • Missouri
      • Jefferson City, Missouri, United States
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States
        • Research Site
    • New York
      • Great Neck, New York, United States
        • Research Site
      • New York, New York, United States
        • Research Site
    • North Carolina
      • Asheville, North Carolina, United States
        • Research Site
      • Elkin, North Carolina, United States
        • Research Site
      • Fayetteville, North Carolina, United States
        • Research Site
      • Greensboro, North Carolina, United States
        • Research Site
      • Harrisburg, North Carolina, United States
        • Research Site
      • Morgantown, North Carolina, United States
        • Research Site
      • Wilmington, North Carolina, United States
        • Research Site
      • Winston-salem, North Carolina, United States
        • Research Site
    • Ohio
      • Akron, Ohio, United States
        • Research Site
      • Canton, Ohio, United States
        • Research Site
    • Oklahoma
      • Norman, Oklahoma, United States
        • Research Site
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • Oregon
      • Portland, Oregon, United States
        • Research Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States
        • Research Site
      • Harrisburg, Pennsylvania, United States
        • Research Site
      • Sayre, Pennsylvania, United States
        • Research Site
    • Rhode Island
      • Cranston, Rhode Island, United States
        • Research Site
    • South Carolina
      • Anderson, South Carolina, United States
        • Research Site
      • Simpsonville, South Carolina, United States
        • Research Site
    • Tennessee
      • Chattanooga, Tennessee, United States
        • Research Site
      • Germantown, Tennessee, United States
        • Research Site
      • Jackson, Tennessee, United States
        • Research Site
      • Johnson City, Tennessee, United States
        • Research Site
      • Knoxville, Tennessee, United States
        • Research Site
      • Nashville, Tennessee, United States
        • Research Site
    • Texas
      • Houston, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
    • Utah
      • Ogden, Utah, United States
        • Research Site
    • Virginia
      • Charlottesville, Virginia, United States
        • Research Site
      • Chesapeake, Virginia, United States
        • Research Site
      • Christiansburg, Virginia, United States
        • Research Site
      • Newport News, Virginia, United States
        • Research Site
      • Norfolk, Virginia, United States
        • Research Site
      • Richmond, Virginia, United States
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • Research Site
      • Waukesha, Wisconsin, United States
        • Research Site
      • West End, Wisconsin, 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 to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject able to read and write US english and able to use electronic devices
  • Subjects who have experienced GERD symptoms for at least six months
  • Subjects currently taking a prescription or over-the-counter PPI medications for GERD
  • Body Mass Index (BMI) 18.5-35.0, inclusive

Exclusion Criteria:

  • Subjects that have not experienced any GERD symptoms improvement at all after PPI treatment
  • Subjects who have any of the following conditions or diseases- Heart disease, Angina, Seizure disorders such as epilepsy, Congestive Heart Failure (CHF), Liver disease such as Cirrhosis or Hepatitis, Kidney disease, Lung disease or lung cancer, Cancer
  • Prior surgery of the upper Gastrointestinal (GI) tract

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

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Gelusil®
Chewable tablets taken as needed
Drug: Placebo
capsule. administered as a single dose twice daily for 4 weeks
EXPERIMENTAL: AZD3355
Drug: AZD3355
Immediate Release capsule administered as a single dose, 65mg, twice daily for 4 weeks
Other Names:
  • Lesogaberan
Drug: Gelusil®
Chewable tablets taken as needed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom Intensity Rated by Participants Twice Daily Using an Electronic Reflux Symptom Questionnaire Diary
Time Frame: Run-in period of 8-12 days and treatment period of 26-30 days
Symptom intensity rated on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe)
Run-in period of 8-12 days and treatment period of 26-30 days

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Nimish Vakil, MD, Aurora Health Center/Waukesha

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.

General Publications

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

May 1, 2008

Primary Completion (ACTUAL)

January 1, 2009

Study Completion (ACTUAL)

January 1, 2009

Study Registration Dates

First Submitted

June 19, 2008

First Submitted That Met QC Criteria

June 19, 2008

First Posted (ESTIMATE)

June 23, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 20, 2011

Last Update Submitted That Met QC Criteria

May 20, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9120C00027

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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