Determination of the Minimal Clinically Important Difference After Treatment With Pantoprazole in Patients With Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/M3-340)
Information source: ALTANA Pharma
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroesophageal Reflux
Intervention: Pantoprazole (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: ALTANA Pharma Official(s) and/or principal investigator(s):
Hartmut Heinze, PhD, Study Chair, Affiliation: Altana Pharma, D-78467 Konstanz, Germany
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.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Primary outcome: ReQuest(tm) scores after one week of treatment.
Secondary outcome: other symptom assessmentssafety.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
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Additional Information
Starting date: November 2005
Last updated: May 14, 2007
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