Study of Long-Term Use of Proton-Pump-Inhibitors in General Practice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00363701
Recruitment Status : Unknown
Verified August 2006 by Glostrup University Hospital, Copenhagen.
Recruitment status was:  Recruiting
First Posted : August 15, 2006
Last Update Posted : August 15, 2006
Information provided by:
Glostrup University Hospital, Copenhagen

August 14, 2006
August 15, 2006
August 15, 2006
August 2006
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Comparison of the effect of treatment in one week with esomeprazole and placebo measured as symptomscore in patientdiary.
Same as current
No Changes Posted
  • Fraction of patients who are willing to withdraw treatment with PPI
  • Fraction of patients who experience symptoms after withdrawal of treatment.
  • Description of endoscopic findings in patients who have previously been treated with PPI long-term and who after withdrawal are symptomatic
  • Length of time from withdrawal till symptoms arise
  • Correlation between levels of gastrin and CgA and time till symptoms arise
  • Investigators and patients ability to distinguish between active and placebo treatment
Same as current
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Study of Long-Term Use of Proton-Pump-Inhibitors in General Practice
With-Drawal Study of Proton-Pump-Inhibitors in Patients From Primary Care Who Have Previously Been Treated on a Long-Term Basis
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.

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.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Dyspepsia
  • Gastroesophageal Refluxdisease
  • Ulcer
Drug: esomeprazole
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
February 2008
Not Provided

Inclusion Criteria:

  • Treatment with PPI in at least 4 months out of the preceding 12.
  • Use of PPI in the preceding 10 out of 30 days before inclusion
  • Age above 18 years

Exclusion Criteria:

  • Erosive Esophagitis
  • PPI-treatment as prophylaxis against gastrointestinal bleeding
  • PPI-treatment as prophylaxis against ulcers
  • PPI-treatment as prophylaxis because of NSAID-treatment
  • Pregnant or lactating women
  • Previous upper GI surgery
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Glostrup University Hospital, Copenhagen
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Principal Investigator: Peter Bytzer, ass. professor, ph.d Glostrup University Hospital
Glostrup University Hospital, Copenhagen
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP