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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pantoprazole 20 mg (drug) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of patients taking 6 or more tablets on-demand per week (averaged from week 5-17. |
| Measure | Description | Time Frame |
|---|---|---|
| -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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mattijs E Numans, MD, PhD | Julius Center for Health Sciences and Primary Care | Study Chair |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D010437 | Peptic Ulcer |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000077402 | Pantoprazole |
| D004364 | Pharmaceutical Preparations |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| -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 |
| -cost-effectiveness |
| D004066 | Digestive System Diseases |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D013272 | Stomach Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |