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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2006 by Glostrup University Hospital, Copenhagen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT00363701
First received: August 14, 2006
Last updated: NA
Last verified: August 2006
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Glostrup University Hospital, Copenhagen:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 150
Study Start Date: August 2006
Estimated Study Completion Date: February 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00363701

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

Locations
Denmark
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
Investigators
Principal Investigator: Peter Bytzer, ass. professor, ph.d Glostrup University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00363701     History of Changes
Other Study ID Numbers: 001
Study First Received: August 14, 2006
Last Updated: August 14, 2006
Health Authority: Denmark: Drug Administration
Denmark: Data inspection institute

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

Additional relevant MeSH terms:
Dyspepsia
Ulcer
Signs and Symptoms, Digestive
Signs and Symptoms
Pathologic Processes
Omeprazole
Proton Pump Inhibitors
 Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013