Determination of the Minimal Clinically Important Difference After Treatment With Pantoprazole in Patients With Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/M3-340)
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Gastroesophageal Reflux |
| Intervention | Drug: Pantoprazole |
| Phase | Phase 4 |
| Sponsor | Takeda |
| Responsible Party | Takeda |
| ClinicalTrials.gov Identifier | NCT00246909 |
| First Received | October 31, 2005 |
| Last Updated | May 4, 2012 |
| Last verified | June 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | October 31, 2005 |
|---|---|
| Last Updated Date | May 4, 2012 |
| Start Date | November 2005 |
| Estimated Primary Completion Date | November 2006 |
| Current Primary Outcome Measures | ReQuest(tm) scores after one week of treatment. |
| Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
| Brief Title | Determination of the Minimal Clinically Important Difference After Treatment With Pantoprazole in Patients With Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/M3-340) |
|---|---|
| Official Title | 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. |
| 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment |
| Condition | Gastroesophageal Reflux |
| Intervention | Drug: Pantoprazole |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 600 |
| Estimated Completion Date | November 2006 |
| Estimated Primary Completion Date | November 2006 |
| Eligibility Criteria | 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00246909 |
|---|---|
| Other Study ID Numbers | BY1023/M3-340 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Takeda |
| Study Sponsor | Takeda |
| Collaborators | Not Provided |
| Investigators | Study Chair: Hartmut Heinze, PhD Altana Pharma, D-78467 Konstanz, Germany |
| Verification Date | June 2011 |
Locations[ + expand ][ + ]
| Altana Pharma/Nycomed | Alabaster, Alabama, United States, 35007 |
|---|---|
| Altana Pharma/Nycomed | Huntsville, Alabama, United States, 35801 |
| Altana Pharma/Nycomed | Mesa, Arizona, United States, 85213 |
| Altana Pharma/Nycomed | Tucson, Arizona, United States, 85723 |
| Altana Pharma/Nycomed | Little Rock, Arkansas, United States, 72117 |
| Altana Pharma/Nycomed | 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, 92123 |
| Altana Pharma/Nycomed | San Diego, California, United States, 92103 |
| Altana Pharma/Nycomed | Wheat Ridge, Colorado, United States, 80033 |
| Altana Pharma/Nycomed | Torrington, Connecticut, United States, 06790 |
| Altana Pharma/Nycomed | Miami, Florida, United States, 33173 |
| Altana Pharma/Nycomed | Pembroke Pines, Florida, United States, 33024 |
| Altana Pharma/Nycomed | Hines, Illinois, United States, 60141 |
| Altana Pharma/Nycomed | Peoria, Illinois, United States, 61602 |
| Altana Pharma/Nycomed | Louisville, Kentucky, United States, 40202 |
| Altana Pharma/Nycomed | Baton Rouge, Louisiana, United States, 70809 |
| Altana Pharma/Nycomed | Shreveport, Louisiana, United States, 71103 |
| Altana Pharma/Nycomed | 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 | Milford, Massachusetts, United States, 01757 |
| Altana Pharma/Nycomed | Jackson, Mississippi, United States, 39202 |
| Altana Pharma/Nycomed | Egg Harbor Township, New Jersey, United States, 08234 |
| Altana Pharma/Nycomed | 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 | Raleigh, North Carolina, United States, 27612 |
| Altana Pharma/Nycomed | Winston-Salem, North Carolina, United States, 27103 |
| Altana Pharma/Nycomed | Cincinnati, Ohio, United States, 45219 |
| Altana Pharma/Nycomed | Medford, Oregon, United States, 97504 |
| Altana Pharma/Nycomed | Duncansville, Pennsylvania, United States, 16635 |
| Altana Pharma/Nycomed | Philadelphia, Pennsylvania, United States, 19147 |
| Altana Pharma/Nycomed | Pittsburg, Pennsylvania, United States, 15218 |
| Altana Pharma/Nycomed | Charleston, South Carolina, United States, 29403 |
| Altana Pharma/Nycomed | Chattanooga, Tennessee, United States, 37404 |
| Altana Pharma/Nycomed | Nashville, Tennessee, United States, 37205 |
| Altana Pharma/Nycomed | Houston, Texas, United States, 77074 |
| Altana Pharma/Nycomed | Houston, Texas, United States, 77090 |
| Altana Pharma/Nycomed | Houston, Texas, United States, 77024 |
| Altana Pharma/Nycomed | Salt Lake Citey, Utah, United States, 84107 |
| Altana Pharma/Nycomed | South Ogden, Utah, United States, 84405 |
| Altana Pharma/Nycomed | Fairfax, Virginia, United States, 22031 |
| Altana Pharma/Nycomed | Bellevue, Washington, United States, 98004 |
| Altana Pharma/Nycomed | Milwaukee, Wisconsin, United States, 53233 |