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

Phase 4

• Conditions: Healthy

• Registration Number: NCT00526006
• Lead Sponsor: Zealand University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-08
• Study Start: 2007-09
• Study First Submitted: 2007-09-05
• Study First Submitted QC: 2007-09-05
• Last Update Submitted: 2007-09-05
• Study First Posted: 2007-09-06
• Last Update Posted: 2007-09-06
• Study Completion: 2008-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Symptom scores in the reflux part of the GSRS after withdrawal of active treatment in the actively treated group versus the placebo group

Trial Locations

Locations (1)

University Hospital Køgw; 🇩🇰 Koge, Denmark