On-Demand Use of Pantoprazole: Determinants for Chronic Use of Acid Suppressive Medication
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|ClinicalTrials.gov Identifier: NCT00161096|
Recruitment Status : Unknown
Verified November 2004 by UMC Utrecht.
Recruitment status was: Active, not recruiting
First Posted : September 12, 2005
Last Update Posted : February 2, 2006
|Condition or disease||Intervention/treatment||Phase|
|Chronic Use of Acid Suppressive Medication GORD GERD Reflux Peptic Ulcer||Drug: pantoprazole 20 mg (drug)||Phase 3|
2-5% of the general population is chronic user of acid suppressing medication (proton pump inhibitors, H2 receptor antagonists), mostly because of gastro-oesophageal reflux disease (GORD). Prescription data from health insurances show that the number of chronic users increases every year, which has large economic consequences.
There are indications however that on-demand and intermittent therapy can be as effective as daily use. No evidence exists regarding patients who are likely to benefit from intermittent, on-demand therapy or even termination.
In this study several aspects of chronic use of acid suppressive therapy are investigated in family practice patients.
Chronic users are transferred to pantoprazole 20 mg for 4 weeks. Patients with adequate relief of symptoms are randomized in two groups for a period of 13 weeks.
group 1: daily pantoprazole 20 mg, placebo on-demand (indicative for placebo-dependency) group 2: daily placebo, pantoprazole 20 mg on-demand (indicative for pharmacological dependency) Patients visit the research nurse at the beginning of the study and at week 4, 5, 10 and 17.
In this study we are looking for patient characteristics indicative for the dependency on acid suppressive drugs and for possibilities to reduce the dose of these drugs.
Furthermore, aspects described in "secondary outcomes" will be addressed.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||276 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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.|
|Study Start Date :||March 2004|
|Study Completion Date :||September 2005|
- 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)
- -proportion of patients successfully changed from omeprazole to pantoprazole, or from 40 mg to 20 mg
- -costs during all phases
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161096
|Study Chair:||Mattijs E Numans, MD, PhD||Julius Center for Health Sciences and Primary Care|