Comparison of the Percentage Chronic on-Demand Users Treated With 20 Mg Pantoprazole on-Demand and Placebo o.d Versus Placebo on-Demand and 20 Mg Pantoprazole o.d. After Symptom Relief With 20 Mg Pantoprazole o.d.
Sponsor study identifier
interventional
276
0 countries
N/A
Study Start
March 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
The purpose of this study is to investigate several aspects of chronic use of acid suppressing medication: dependence on maintenance therapy, the possibilities for on-demand use, and predictors (patient characteristics) for daily need, for on-demand use and for termination of chronic use.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2004
Date type not reportedThis date has not been verified as actual or estimated.
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
September 8, 2005
Actual (reported)September 12, 2005
Actual (reported)The percentage of patients taking 6 or more tablets on-demand per week (averaged from week 5-17.
-mean weakly consumption of on-demand tablets
-percentage of patients in placebo group requiring less than 2 tablets pantoprazole per week
-proportion of patients with adequate relief per treatment group per week
-quality of life during double-blind phase (via SF-36 and QOLRAD for GERD symptom score)
-predictors of the primary outcome (age, sex, general medical and gastrointestinal history, Hp status, BMI, lifestyle factors, personality and psychological state)
Mattijs E Numans, MD, PhD
Julius Center for Health Sciences and Primary Care
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
March 2004
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
September 2005
Date type not reportedContact the study team to confirm eligibility.
This date has not been verified as actual or estimated.
Last Updated
February 2, 2006
Record last verified: 2004-11
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Source: ClinicalTrials.gov.
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