Symptom Evaluation After Cessation of a Proton Pump Inhibitor in Healthy Volunteers

Healthy Clinical Trial

Official title:

Symptom Evaluation After Cessation of a Proton Pump Inhibitor in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00915239
• Other study ID #: SUS/KUS2
• Status: Completed
• Phase: N/A
• First received: June 4, 2009
• Last updated: June 4, 2009
• Start date: January 2006
• Est. completion date: October 2006

Study information

• Verified date: June 2009
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers

• 18-70 years of age

• Informed consent

• No prior history of any GI disorder

Exclusion Criteria:

• Dyspeptic complaints

• H. pylori infection

• Ongoing treatment with pain-relieving medications (i.e., NSAID)

• Pregnancy or breast feeding

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Pantoprazole
40 mg pantoprazole once daily for 28 days
• Placebo
identical placebo once daily for 28 days

Locations

Country	Name	City	State
Sweden	Sahlgrenska Univeristy Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate whether healthy volunteers, treated with PPI for four weeks, develop acid-related symptoms after cessation of PPI therapy.			No
Secondary	To evaluate whether there is a correlation between markers for acid secretion such as gastrin and chromogranin-A and the development of dyspeptic symptoms.