PPI-Rebound-Trial. A Study of the Clinical Relevance of the Acid Rebound Phenomena
Sponsor
Zealand University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT00526006
Collaborator
(none)
1
6
Study Details
Study Description
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 |
|---|---|---|
| Phase 4 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date
:
Sep 1, 2007
Anticipated Study Completion Date
:
Mar 1, 2008
Outcome Measures
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 []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Køgw | Koge | Denmark | 4600 |
Sponsors and Collaborators
- Zealand University Hospital
Investigators
- Principal Investigator: Christina Reimer, MD, University Hospital Køge
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00526006
Other Study ID Numbers:
- 2006-00673-145
First Posted:
Sep 6, 2007
Last Update Posted:
Sep 6, 2007
Last Verified:
Aug 1, 2007
Keywords provided by ,
,
Additional relevant MeSH terms: