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

Gastroesophageal Reflux Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00246909
• Other study ID #: BY1023/M3-340
• Status: Completed
• Phase: Phase 4
• First received: October 31, 2005
• Last updated: May 4, 2012
• Start date: November 2005
• Est. completion date: November 2006

Study information

• Verified date: June 2011
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Drug:
• Pantoprazole

Locations

Country	Name	City	State
United States	Altana Pharma/Nycomed	Alabaster	Alabama
United States	Altana Pharma/Nycomed	Anaheim	California
United States	Altana Pharma/Nycomed	Baton Rouge	Louisiana
United States	Altana Pharma/Nycomed	Bellevue	Washington
United States	Altana Pharma/Nycomed	Bethesda	Maryland
United States	Altana Pharma/Nycomed	Charleston	South Carolina
United States	Altana Pharma/Nycomed	Chattanooga	Tennessee
United States	Altana Pharma/Nycomed	Cincinnati	Ohio
United States	Altana Pharma/Nycomed	Duncansville	Pennsylvania
United States	Altana Pharma/Nycomed	Egg Harbor Township	New Jersey
United States	Altana Pharma/Nycomed	Fairfax	Virginia
United States	Altana Pharma/Nycomed	Great Neck	New York
United States	Altana Pharma/Nycomed	Great Neck	New York
United States	Altana Pharma/Nycomed	Hines	Illinois
United States	Altana Pharma/Nycomed	Hollywood	Maryland
United States	Altana Pharma/Nycomed	Houston	Texas
United States	Altana Pharma/Nycomed	Houston	Texas
United States	Altana Pharma/Nycomed	Houston	Texas
United States	Altana Pharma/Nycomed	Huntsville	Alabama
United States	Altana Pharma/Nycomed	Jackson	Mississippi
United States	Altana Pharma/Nycomed	Johnson City	New York
United States	Altana Pharma/Nycomed	Laurel	Maryland
United States	Altana Pharma/Nycomed	Little Rock	Arkansas
United States	Altana Pharma/Nycomed	Los Angeles	California
United States	Altana Pharma/Nycomed	Louisville	Kentucky
United States	Altana Pharma/Nycomed	Medford	Oregon
United States	Altana Pharma/Nycomed	Mesa	Arizona
United States	Altana Pharma/Nycomed	Miami	Florida
United States	Altana Pharma/Nycomed	Milford	Massachusetts
United States	Altana Pharma/Nycomed	Milwaukee	Wisconsin
United States	Altana Pharma/Nycomed	Nashville	Tennessee
United States	Altana Pharma/Nycomed	Orange	California
United States	Altana Pharma/Nycomed	Orange	California
United States	Altana Pharma/Nycomed	Pembroke Pines	Florida
United States	Altana Pharma/Nycomed	Peoria	Illinois
United States	Altana Pharma/Nycomed	Philadelphia	Pennsylvania
United States	Altana Pharma/Nycomed	Pittsburg	Pennsylvania
United States	Altana Pharma/Nycomed	Raleigh	North Carolina
United States	Altana Pharma/Nycomed	Redwood City	California
United States	Altana Pharma/Nycomed	Rochester	New York
United States	Altana Pharma/Nycomed	Salt Lake Citey	Utah
United States	Altana Pharma/Nycomed	San Diego	California
United States	Altana Pharma/Nycomed	San Diego	California
United States	Altana Pharma/Nycomed	Shreveport	Louisiana
United States	Altana Pharma/Nycomed	South Ogden	Utah
United States	Altana Pharma/Nycomed	Torrington	Connecticut
United States	Altana Pharma/Nycomed	Towson	Maryland
United States	Altana Pharma/Nycomed	Tucson	Arizona
United States	Altana Pharma/Nycomed	Washington	Maryland
United States	Altana Pharma/Nycomed	Wheat Ridge	Colorado
United States	Altana Pharma/Nycomed	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ReQuest(tm) scores after one week of treatment.
Secondary	other symptom assessments
Secondary	safety.