Determination of the Minimal Clinically Important Difference After Treatment With Pantoprazole in Patients With Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/M3-340)
1 other identifier
interventional
600
1 country
51
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2005
Shorter than P25 for phase_4
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2005
CompletedFirst Posted
Study publicly available on registry
November 1, 2005
CompletedStudy Start
First participant enrolled
November 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedMay 7, 2012
June 1, 2011
1 year
October 31, 2005
May 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ReQuest(tm) scores after one week of treatment.
Secondary Outcomes (2)
other symptom assessments
safety.
Interventions
Eligibility Criteria
You may qualify if:
- In general good health other than gastroesophageal reflux disease (GERD)
- Endoscopically confirmed gastroesophageal reflux disease
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (51)
Altana Pharma/Nycomed
Alabaster, Alabama, 35007, United States
Altana Pharma/Nycomed
Huntsville, Alabama, 35801, United States
Altana Pharma/Nycomed
Mesa, Arizona, 85213, United States
Altana Pharma/Nycomed
Tucson, Arizona, 85723, United States
Altana Pharma/Nycomed
Little Rock, Arkansas, 72117, United States
Altana Pharma/Nycomed
Anaheim, California, 92801, United States
Altana Pharma/Nycomed
Los Angeles, California, 90073, United States
Altana Pharma/Nycomed
Orange, California, 92868, United States
Altana Pharma/Nycomed
Orange, California, 92869, United States
Altana Pharma/Nycomed
Redwood City, California, 94062, United States
Altana Pharma/Nycomed
San Diego, California, 92103, United States
Altana Pharma/Nycomed
San Diego, California, 92123, United States
Altana Pharma/Nycomed
Wheat Ridge, Colorado, 80033, United States
Altana Pharma/Nycomed
Torrington, Connecticut, 06790, United States
Altana Pharma/Nycomed
Miami, Florida, 33173, United States
Altana Pharma/Nycomed
Pembroke Pines, Florida, 33024, United States
Altana Pharma/Nycomed
Hines, Illinois, 60141, United States
Altana Pharma/Nycomed
Peoria, Illinois, 61602, United States
Altana Pharma/Nycomed
Louisville, Kentucky, 40202, United States
Altana Pharma/Nycomed
Baton Rouge, Louisiana, 70809, United States
Altana Pharma/Nycomed
Shreveport, Louisiana, 71103, United States
Altana Pharma/Nycomed
Bethesda, Maryland, 20814, United States
Altana Pharma/Nycomed
Hollywood, Maryland, 20636, United States
Altana Pharma/Nycomed
Laurel, Maryland, 20707, United States
Altana Pharma/Nycomed
Reisterstown, Maryland, 20010, United States
Altana Pharma/Nycomed
Towson, Maryland, 21204, United States
Altana Pharma/Nycomed
Milford, Massachusetts, 01757, United States
Altana Pharma/Nycomed
Jackson, Mississippi, 39202, United States
Altana Pharma/Nycomed
Egg Harbor, New Jersey, 08234, United States
Altana Pharma/Nycomed
Great Neck, New York, 11021, United States
Altana Pharma/Nycomed
Great Neck, New York, 11023, United States
Altana Pharma/Nycomed
Johnson City, New York, 13790, United States
Altana Pharma/Nycomed
Rochester, New York, 14609, United States
Altana Pharma/Nycomed
Raleigh, North Carolina, 27612, United States
Altana Pharma/Nycomed
Winston-Salem, North Carolina, 27103, United States
Altana Pharma/Nycomed
Cincinnati, Ohio, 45219, United States
Altana Pharma/Nycomed
Medford, Oregon, 97504, United States
Altana Pharma/Nycomed
Duncansville, Pennsylvania, 16635, United States
Altana Pharma/Nycomed
Philadelphia, Pennsylvania, 19147, United States
Altana Pharma/Nycomed
Pittsburgh, Pennsylvania, 15218, United States
Altana Pharma/Nycomed
Charleston, South Carolina, 29403, United States
Altana Pharma/Nycomed
Chattanooga, Tennessee, 37404, United States
Altana Pharma/Nycomed
Nashville, Tennessee, 37205, United States
Altana Pharma/Nycomed
Houston, Texas, 77024, United States
Altana Pharma/Nycomed
Houston, Texas, 77074, United States
Altana Pharma/Nycomed
Houston, Texas, 77090, United States
Altana Pharma/Nycomed
Salt Lake Citey, Utah, 84107, United States
Altana Pharma/Nycomed
South Ogden, Utah, 84405, United States
Altana Pharma/Nycomed
Fairfax, Virginia, 22031, United States
Altana Pharma/Nycomed
Bellevue, Washington, 98004, United States
Altana Pharma/Nycomed
Milwaukee, Wisconsin, 53233, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hartmut Heinze, PhD
Altana Pharma, D-78467 Konstanz, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 31, 2005
First Posted
November 1, 2005
Study Start
November 1, 2005
Primary Completion
November 1, 2006
Study Completion
November 1, 2006
Last Updated
May 7, 2012
Record last verified: 2011-06