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
Recruitment status was Recruiting
Sponsor:
University Hospital Koge
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
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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:
Drug Information available for:
Omeprazole
Omeprazole magnesium
Esomeprazole
Esomeprazole Sodium
Esomeprazole magnesium
U.S. FDA Resources
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
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:
|
Omeprazole Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses |
Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013