Clinical trial NCT00246909: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastroesophageal Reflux
Keywords: Gastroesophageal Reflux
Gastroesophageal Reflux Disease
Pantoprazole
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-11-01
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: ReQuest(tm) scores after one week of treatment.
Secondary outcomes:
measure: other symptom assessments
measure: safety.
Other outcomes:
Locations:
city: Alabaster
country: United States
facility: Altana Pharma/Nycomed
state: Alabama
city: Huntsville
country: United States
facility: Altana Pharma/Nycomed
state: Alabama
city: Mesa
country: United States
facility: Altana Pharma/Nycomed
state: Arizona
city: Tucson
country: United States
facility: Altana Pharma/Nycomed
state: Arizona
city: Little Rock
country: United States
facility: Altana Pharma/Nycomed
state: Arkansas
city: Anaheim
country: United States
facility: Altana Pharma/Nycomed
state: California
city: Los Angeles
country: United States
facility: Altana Pharma/Nycomed
state: California
city: Orange
country: United States
facility: Altana Pharma/Nycomed
state: California
city: Orange
country: United States
facility: Altana Pharma/Nycomed
state: California
city: Redwood City
country: United States
facility: Altana Pharma/Nycomed
state: California
city: San Diego
country: United States
facility: Altana Pharma/Nycomed
state: California
city: San Diego
country: United States
facility: Altana Pharma/Nycomed
state: California
city: Wheat Ridge
country: United States
facility: Altana Pharma/Nycomed
state: Colorado
city: Torrington
country: United States
facility: Altana Pharma/Nycomed
state: Connecticut
city: Miami
country: United States
facility: Altana Pharma/Nycomed
state: Florida
city: Pembroke Pines
country: United States
facility: Altana Pharma/Nycomed
state: Florida
city: Hines
country: United States
facility: Altana Pharma/Nycomed
state: Illinois
city: Peoria
country: United States
facility: Altana Pharma/Nycomed
state: Illinois
city: Louisville
country: United States
facility: Altana Pharma/Nycomed
state: Kentucky
city: Baton Rouge
country: United States
facility: Altana Pharma/Nycomed
state: Louisiana
city: Shreveport
country: United States
facility: Altana Pharma/Nycomed
state: Louisiana
city: Bethesda
country: United States
facility: Altana Pharma/Nycomed
state: Maryland
city: Hollywood
country: United States
facility: Altana Pharma/Nycomed
state: Maryland
city: Laurel
country: United States
facility: Altana Pharma/Nycomed
state: Maryland
city: Towson
country: United States
facility: Altana Pharma/Nycomed
state: Maryland
city: Washington
country: United States
facility: Altana Pharma/Nycomed
state: Maryland
city: Milford
country: United States
facility: Altana Pharma/Nycomed
state: Massachusetts
city: Jackson
country: United States
facility: Altana Pharma/Nycomed
state: Mississippi
city: Egg Harbor Township
country: United States
facility: Altana Pharma/Nycomed
state: New Jersey
city: Great Neck
country: United States
facility: Altana Pharma/Nycomed
state: New York
city: Great Neck
country: United States
facility: Altana Pharma/Nycomed
state: New York
city: Johnson City
country: United States
facility: Altana Pharma/Nycomed
state: New York
city: Rochester
country: United States
facility: Altana Pharma/Nycomed
state: New York
city: Raleigh
country: United States
facility: Altana Pharma/Nycomed
state: North Carolina
city: Winston-Salem
country: United States
facility: Altana Pharma/Nycomed
state: North Carolina
city: Cincinnati
country: United States
facility: Altana Pharma/Nycomed
state: Ohio
city: Medford
country: United States
facility: Altana Pharma/Nycomed
state: Oregon
city: Duncansville
country: United States
facility: Altana Pharma/Nycomed
state: Pennsylvania
city: Philadelphia
country: United States
facility: Altana Pharma/Nycomed
state: Pennsylvania
city: Pittsburg
country: United States
facility: Altana Pharma/Nycomed
state: Pennsylvania
city: Charleston
country: United States
facility: Altana Pharma/Nycomed
state: South Carolina
city: Chattanooga
country: United States
facility: Altana Pharma/Nycomed
state: Tennessee
city: Nashville
country: United States
facility: Altana Pharma/Nycomed
state: Tennessee
city: Houston
country: United States
facility: Altana Pharma/Nycomed
state: Texas
city: Houston
country: United States
facility: Altana Pharma/Nycomed
state: Texas
city: Houston
country: United States
facility: Altana Pharma/Nycomed
state: Texas
city: Salt Lake Citey
country: United States
facility: Altana Pharma/Nycomed
state: Utah
city: South Ogden
country: United States
facility: Altana Pharma/Nycomed
state: Utah
city: Fairfax
country: United States
facility: Altana Pharma/Nycomed
state: Virginia
city: Bellevue
country: United States
facility: Altana Pharma/Nycomed
state: Washington
city: Milwaukee
country: United States
facility: Altana Pharma/Nycomed
state: Wisconsin
Study officials:
affiliation: Altana Pharma, D-78467 Konstanz, Germany
name: Hartmut Heinze, PhD
role: STUDY_CHAIR
References: