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

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ClinicalTrials.gov 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

Brief Summary:
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 or disease Intervention/treatment Phase
Dyspepsia Gastroesophageal Refluxdisease Ulcer Drug: esomeprazole Phase 4

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: With-Drawal Study of Proton-Pump-Inhibitors in Patients From Primary Care Who Have Previously Been Treated on a Long-Term Basis
Study Start Date : August 2006
Estimated Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Comparison of the effect of treatment in one week with esomeprazole and placebo measured as symptomscore in patientdiary.

Secondary Outcome Measures :
  1. Fraction of patients who are willing to withdraw treatment with PPI
  2. Fraction of patients who experience symptoms after withdrawal of treatment.
  3. Description of endoscopic findings in patients who have previously been treated with PPI long-term and who after withdrawal are symptomatic
  4. Length of time from withdrawal till symptoms arise
  5. Correlation between levels of gastrin and CgA and time till symptoms arise
  6. Investigators and patients ability to distinguish between active and placebo treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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): NCT00363701

Contact: Christina Reimer, MD +45 43 23 27 79 chrrei01@glostruphosp.kbhamt.dk

Department of gastroenterology, Glostrup University Hospital Recruiting
Glostrup, Denmark, 2600
Contact: Christina Reimer, MD    43 23 27 79    chrrei01@glostruphosp.kbhamt.dk   
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Principal Investigator: Peter Bytzer, ass. professor, ph.d Glostrup University Hospital

ClinicalTrials.gov Identifier: NCT00363701     History of Changes
Other Study ID Numbers: 001
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: August 15, 2006
Last Verified: August 2006

Keywords provided by Glostrup University Hospital, Copenhagen:
longterm treatment
functional dyspepsia
gastrooesophageal reflux
upper endoscopy

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action