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| Sponsored by: |
Glostrup University Hospital,Copenhagen |
|---|---|
| Information provided by: | Glostrup University Hospital,Copenhagen |
| ClinicalTrials.gov Identifier: | NCT00363701 |
Purpose
The primary purpose of the study is to determine the effect of esomeprazole compared to placebo in patients from general practice who have previously been treated with proton-pump-inhibitors (PPI) and who have no upper endoscopic findings.
| Condition | Intervention | Phase |
|---|---|---|
|
Dyspepsia Gastroesophageal Refluxdisease Ulcer |
Drug: esomeprazole |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | With-Drawal Study of Proton-Pump-Inhibitors in Patients From Primary Care Who Have Previously Been Treated on a Long-Term Basis |
| Estimated Enrollment: | 150 |
| Study Start Date: | August 2006 |
| Estimated Study Completion Date: | February 2008 |
The majority of patients with dyspepsia are treated in primary care with acid-suppressive therapy for shorter or longer periods of time on the assumption that the patients´ symptoms are related to the production of acid in the stomach. In about half of the dyspeptic patients there is no structural or biochemical explanation for their symptoms.
These patients suffer from functional dyspepsia. Treatment with proton-pump-inhibitors is effective in treating patients with gastroesophageal refluxdisease or ulcers. It is however controversial if acid-suppressive treatment is effective in the large group of patients with functional dyspepsia. Previous studies have shown no or very modest effect with a very high placeboresponse rate of 40-50%. In primary care patients with upper abdominal symptoms are often treated with PPI as a diagnostic tool. If the treatment is effective continued or repeated treatment with PPI is often favored. However some of the patients must experience the abovementioned placebo-effect. These patients may end up being treated with PPI long-term on uncertain indication. We wish to investigate the consequences of withdrawing treatment with PPI in patients from general practice who have previously been treated long-term. An upper endoscopy is performed in patients who experience upper abdominal symptoms after withdrawal of treatment.If the endoscopy is normal patients are randomised to 1 week treatment with either esomeprazole or placebo.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Christina Reimer, MD | +45 43 23 27 79 | chrrei01@glostruphosp.kbhamt.dk |
| Denmark | |
| Department of gastroenterology, Glostrup University Hospital | Recruiting |
| Glostrup, Denmark, 2600 | |
| Contact: Christina Reimer, MD 43 23 27 79 chrrei01@glostruphosp.kbhamt.dk | |
| Principal Investigator: | Peter Bytzer, ass. professor, ph.d | Glostrup University Hospital |
More Information
| Study ID Numbers: | 001 |
| Study First Received: | August 14, 2006 |
| Last Updated: | August 14, 2006 |
| ClinicalTrials.gov Identifier: | NCT00363701 History of Changes |
| Health Authority: | Denmark: Drug Administration; Denmark: Data inspection institute |
|
Protonpumpinhibitors withdrawal longterm treatment dyspepsia |
functional dyspepsia gastrooesophageal reflux upper endoscopy |
|
Signs and Symptoms Proton Pump Inhibitors Signs and Symptoms, Digestive Ulcer |
Omeprazole Dyspepsia Gastroesophageal Reflux |
|
Signs and Symptoms Molecular Mechanisms of Pharmacological Action Proton Pump Inhibitors Signs and Symptoms, Digestive Therapeutic Uses Anti-Ulcer Agents |
Gastrointestinal Agents Omeprazole Enzyme Inhibitors Dyspepsia Pharmacologic Actions |
