Determination of the Minimal Clinically Important Difference After Treatment With Pantoprazole in Patients With Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/M3-340)

May 4, 2012 updated by: Takeda

Determination of the Minimal Clinically Important Difference (MCID) of the Patient Orientated Self Assessment Scale ReQuest TradeMark in Patients Suffering From Endoscopically Confirmed Gastroesophageal Reflux Disease (GERD), Grade A-D According to Los Angeles Classification Treated With Pantoprazole 40 mg o.d. or Placebo o.d. Over One Week.

Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and esophagus. GERD occurs when the lower esophageal sphincter does not close properly and stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common medical disorders, with estimates of up to 50% of adults reporting reflux symptoms daily. Proton pump inhibitors such as pantoprazole can relieve symptoms of GERD in a large proportion of patients.

Of particular interest in GERD is the assessment of symptom severity and quality of life, and the response of these parameters to treatment. Therefore, a questionnaire to assess GERD symptoms was developed (ReQuest TradeMark). An important point to consider when using such a questionnaire is to evaluate whether an observed difference in scores after a certain treatment represents a clinical effect.

The aim of this study is to determine the minimal clinically important difference (MCID) in patients diagnosed with GERD. During the study, the patients will complete a patient-orientated, self-assessed reflux questionnaire (ReQuest TradeMark). Endoscopy will be performed at the start of the study. The study duration consists of a baseline period (1 to 3 weeks) and a treatment period (8 weeks). During the first treatment week, the patients will receive either pantoprazole (tablet) or placebo once daily in the morning; for the following 7 treatment weeks all patients will receive pantoprazole. The study will provide further data on safety and tolerability of pantoprazole.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

600

Phase

  • Phase 4

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
      • Alabaster, Alabama, United States, 35007
        • Altana Pharma/Nycomed
      • Huntsville, Alabama, United States, 35801
        • Altana Pharma/Nycomed
    • Arizona
      • Mesa, Arizona, United States, 85213
        • Altana Pharma/Nycomed
      • Tucson, Arizona, United States, 85723
        • Altana Pharma/Nycomed
    • Arkansas
      • Little Rock, Arkansas, United States, 72117
        • Altana Pharma/Nycomed
    • California
      • Anaheim, California, United States, 92801
        • Altana Pharma/Nycomed
      • Los Angeles, California, United States, 90073
        • Altana Pharma/Nycomed
      • Orange, California, United States, 92868
        • Altana Pharma/Nycomed
      • Orange, California, United States, 92869
        • Altana Pharma/Nycomed
      • Redwood City, California, United States, 94062
        • Altana Pharma/Nycomed
      • San Diego, California, United States, 92103
        • Altana Pharma/Nycomed
      • San Diego, California, United States, 92123
        • Altana Pharma/Nycomed
    • Colorado
      • Wheat Ridge, Colorado, United States, 80033
        • Altana Pharma/Nycomed
    • Connecticut
      • Torrington, Connecticut, United States, 06790
        • Altana Pharma/Nycomed
    • Florida
      • Miami, Florida, United States, 33173
        • Altana Pharma/Nycomed
      • Pembroke Pines, Florida, United States, 33024
        • Altana Pharma/Nycomed
    • Illinois
      • Hines, Illinois, United States, 60141
        • Altana Pharma/Nycomed
      • Peoria, Illinois, United States, 61602
        • Altana Pharma/Nycomed
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Altana Pharma/Nycomed
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Altana Pharma/Nycomed
      • Shreveport, Louisiana, United States, 71103
        • Altana Pharma/Nycomed
    • Maryland
      • Bethesda, Maryland, United States, 20814
        • Altana Pharma/Nycomed
      • Hollywood, Maryland, United States, 20636
        • Altana Pharma/Nycomed
      • Laurel, Maryland, United States, 20707
        • Altana Pharma/Nycomed
      • Towson, Maryland, United States, 21204
        • Altana Pharma/Nycomed
      • Washington, Maryland, United States, 20010
        • Altana Pharma/Nycomed
    • Massachusetts
      • Milford, Massachusetts, United States, 01757
        • Altana Pharma/Nycomed
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Altana Pharma/Nycomed
    • New Jersey
      • Egg Harbor Township, New Jersey, United States, 08234
        • Altana Pharma/Nycomed
    • New York
      • Great Neck, New York, United States, 11021
        • Altana Pharma/Nycomed
      • Great Neck, New York, United States, 11023
        • Altana Pharma/Nycomed
      • Johnson City, New York, United States, 13790
        • Altana Pharma/Nycomed
      • Rochester, New York, United States, 14609
        • Altana Pharma/Nycomed
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Altana Pharma/Nycomed
      • Winston-Salem, North Carolina, United States, 27103
        • Altana Pharma/Nycomed
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Altana Pharma/Nycomed
    • Oregon
      • Medford, Oregon, United States, 97504
        • Altana Pharma/Nycomed
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altana Pharma/Nycomed
      • Philadelphia, Pennsylvania, United States, 19147
        • Altana Pharma/Nycomed
      • Pittsburg, Pennsylvania, United States, 15218
        • Altana Pharma/Nycomed
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Altana Pharma/Nycomed
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Altana Pharma/Nycomed
      • Nashville, Tennessee, United States, 37205
        • Altana Pharma/Nycomed
    • Texas
      • Houston, Texas, United States, 77024
        • Altana Pharma/Nycomed
      • Houston, Texas, United States, 77074
        • Altana Pharma/Nycomed
      • Houston, Texas, United States, 77090
        • Altana Pharma/Nycomed
    • Utah
      • Salt Lake Citey, Utah, United States, 84107
        • Altana Pharma/Nycomed
      • South Ogden, Utah, United States, 84405
        • Altana Pharma/Nycomed
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Altana Pharma/Nycomed
    • Washington
      • Bellevue, Washington, United States, 98004
        • Altana Pharma/Nycomed
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53233
        • Altana Pharma/Nycomed

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

Description

Main inclusion criteria:

  • In general good health other than gastroesophageal reflux disease (GERD)
  • History of GERD-related symptoms for at least 6 months prior to inclusion into the study
  • Endoscopically confirmed gastroesophageal reflux disease

Main exclusion criteria:

  • Acute peptic ulcer and/or ulcer complications
  • Systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors on more than 3 consecutive days within the previous 28 days; except regular intake of acetylsalicylic acid in dosages up to 163 mg/day
  • Intake of Proton Pump Inhibitors and Histamine 2-receptor antagonists within the previous 14 days
  • Intake of psychotropic medication, dyspepsia-inducing drugs, and anticholinergic agents
  • Pregnant or nursing female patients; Non-pregnant, non-lactating female patients of childbearing potential who are not using reliable method of contraception

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: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
ReQuest(tm) scores after one week of treatment.

Secondary Outcome Measures

Outcome Measure
safety.
other symptom assessments

Collaborators and Investigators

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

Sponsor

Takeda

Investigators

  • Study Chair: Hartmut Heinze, PhD, Altana Pharma, D-78467 Konstanz, Germany

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, 2005

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

October 31, 2005

First Submitted That Met QC Criteria

October 31, 2005

First Posted (Estimate)

November 1, 2005

Study Record Updates

Last Update Posted (Estimate)

May 7, 2012

Last Update Submitted That Met QC Criteria

May 4, 2012

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BY1023/M3-340

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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