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

Sahlgrenska University Hospital

Status: Completed

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Pantoprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT00915239

SUS/KUS2

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Pantoprazole

Active Comparator group

Treatment:

Drug: Pantoprazole

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo