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NCT00526006 Clinical Trial

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

Healthy Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00526006
Other study ID # 2006-00673-145
Secondary ID
Status Recruiting
Phase Phase 4
First received September 5, 2007
Last updated September 5, 2007
Start date September 2007
Est. completion date March 2008

Study information
Verified date August 2007
Source University Hospital Koge
Contact Christina Reimer, MD
Phone +45 47 32 29 51
Email rkchre@ra.dk
Is FDA regulated No
Health authority Denmark: Danish Medicines AgencyDenmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 0
Est. completion date March 2008
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• esomeprazole
40 mg od for 8 wks

Locations
Country Name City State
Denmark University Hospital Køgw Koge

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Koge

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Symptom scores in the reflux part of the GSRS after withdrawal of active treatment in the actively treated group versus the placebo group
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