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
Sponsor:
Information provided by:
University Hospital Koge
ClinicalTrials.gov Identifier:
NCT00526006
First received: September 5, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  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
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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov 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:
Esomeprazole
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014