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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. The completion date has passed and the status has not been verified in more than two years.
Verified August 2007 by University Hospital Koge.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00526006
First Posted: September 6, 2007
Last Update Posted: September 6, 2007
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.
Information provided by:
University Hospital Koge
  Purpose
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
Healthy Drug: esomeprazole Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
  Eligibility

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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): NCT00526006


Contacts
Contact: Christina Reimer, MD +45 47 32 29 51 rkchre@ra.dk

Locations
Denmark
University Hospital Køgw Recruiting
Koge, Denmark, 4600
Principal Investigator: Chrístina Reimer, MD         
Sponsors and Collaborators
University Hospital Koge
Investigators
Principal Investigator: Christina Reimer, MD University Hospital Køge
  More Information

ClinicalTrials.gov Identifier: NCT00526006     History of Changes
Other Study ID Numbers: 2006-00673-145
First Submitted: September 5, 2007
First Posted: September 6, 2007
Last Update Posted: September 6, 2007
Last Verified: August 2007

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

Additional relevant MeSH terms:
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action