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

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: NCT00526006
Recruitment Status : Unknown
Verified August 2007 by Zealand University Hospital.
Recruitment status was:  Recruiting
First Posted : September 6, 2007
Last Update Posted : September 6, 2007
Information provided by:
Zealand University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: esomeprazole Phase 4

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2007
Estimated Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: esomeprazole
    40 mg od for 8 wks

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 identifier (NCT number): 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
Zealand University Hospital
Principal Investigator: Christina Reimer, MD University Hospital Køge Identifier: NCT00526006     History of Changes
Other Study ID Numbers: 2006-00673-145
First Posted: September 6, 2007    Key Record Dates
Last Update Posted: September 6, 2007
Last Verified: August 2007

Keywords provided by Zealand University Hospital:
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