- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00161096
On-Demand Use of Pantoprazole: Determinants for Chronic Use of Acid Suppressive Medication
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 Overview
Status
Intervention / Treatment
Detailed Description
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
Enrollment
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- male and female (non-pregnant, non-lactating)out-patients between 18-75
- chronic users of acid suppressive therapy for at least 180 days over the last year
Exclusion Criteria:
- stage 3, 4 oesophagitis, Barrett's oesophagus, acute peptic ulcer
- gastric hypersecretory condition, predominantly IBS symptoms, previous gastric/oesophageal surgery, pyloric stenosis
- severe, unstable comorbidities
- alarm symptoms
- malignancies in the past 5 years
- use of NSAID, systemic glucocorticoids, Cox-2 inhibitors, acetylsalicylic acid more than 150 mg daily, drugs with pH-dependent absorption, anticholinergics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
The percentage of patients taking 6 or more tablets on-demand per week (averaged from week 5-17.
|
Secondary Outcome Measures
Outcome Measure |
---|
-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
|
-cost-effectiveness
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Mattijs E Numans, MD, PhD, Julius Center for Health Sciences and Primary Care
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BY1023/NL503
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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