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PPI-Rebound-Trial. A Study of the Clinical Relevance of the Acid Rebound Phenomena

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by University Hospital Koge.
Recruitment status was  Recruiting
Information provided by:
University Hospital Koge Identifier:
First received: September 5, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
The acid secretion in the stomach seems to increase after withdrawal of min. 8 wks of treatment with a PPI (protonpump inhibitor) It is unknown if this acid rebound phenomenon is of clinical significance. In a doubleblinded and placebocontrolled study healthy volunteers are randomized to treatment with placebo or PPI + placebo. Gastrointestinal symptoms are scored once a week and.

Condition Intervention Phase
Drug: esomeprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by University Hospital Koge:

Primary Outcome Measures:
  • Symptom scores in the reflux part of the GSRS after withdrawal of active treatment in the actively treated group versus the placebo group

Study Start Date: September 2007
Estimated Study Completion Date: March 2008
Intervention Details:
    Drug: esomeprazole
    40 mg od for 8 wks

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 18 years +

Exclusion Criteria:

  • Dyspepsia, heartburn og acid regurgitation within the preceeding 4 weeks
  • Previous treatment with PPI og H2RA
  • Previous contact to doctor or hospital because of dyspepsia or reflux
  • Pregnancy or breast feeding
  Contacts and Locations
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Please refer to this study by its identifier: NCT00526006

Contact: Christina Reimer, MD +45 47 32 29 51

University Hospital Køgw Recruiting
Koge, Denmark, 4600
Principal Investigator: Chrístina Reimer, MD         
Sponsors and Collaborators
University Hospital Koge
Principal Investigator: Christina Reimer, MD University Hospital Køge
  More Information Identifier: NCT00526006     History of Changes
Other Study ID Numbers: 2006-00673-145 
Study First Received: September 5, 2007
Last Updated: September 5, 2007
Health Authority: Denmark: Danish Medicines Agency
Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by University Hospital Koge:
Clinical significance of the acid rebound phenomenon after withdrawal of treatment with a PPI

Additional relevant MeSH terms:
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on October 21, 2016