Symptom Evaluation After Cessation of a Proton Pump Inhibitor in Healthy Volunteers
- Registration Number
- NCT00915239
- Lead Sponsor
- Sahlgrenska University Hospital, Sweden
- Brief Summary
The purpose of this study is to determine whether proton pump inhibitor (PPI) induced hypersecretion leads to acid related symptoms after treatment in healthy volunteers.
- Detailed Description
Treatment with proton pump inhibitors (PPI) has been shown to cause rebound hypersecretion of gastric acid. The clinical significance of this phenomenon is however unclear. This study aims to examine whether or not healthy volunteers, who over a relatively short period of time treated with a PPI, develop dyspeptic symptoms after cessation of therapy. Dyspeptic symptoms will be measured subjectively using a validated questionnaire, which is filled out each day. Gastric acid will be measured indirectly with measurement of acid secretion markers (Gastrin and chromogranin-A).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Healthy volunteers
- 18-70 years of age
- Informed consent
- No prior history of any GI disorder
- Dyspeptic complaints
- H. pylori infection
- Ongoing treatment with pain-relieving medications (i.e., NSAID)
- Pregnancy or breast feeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pantoprazole Pantoprazole - Placebo Placebo -
- Primary Outcome Measures
Name Time Method To evaluate whether healthy volunteers, treated with PPI for four weeks, develop acid-related symptoms after cessation of PPI therapy.
- Secondary Outcome Measures
Name Time Method To evaluate whether there is a correlation between markers for acid secretion such as gastrin and chromogranin-A and the development of dyspeptic symptoms.
Trial Locations
- Locations (1)
Sahlgrenska Univeristy Hospital
🇸🇪Gothenburg, Sweden