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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Pantoprazole; Drug: Placebo

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).

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 413 45
    • Sahlgrenska Univeristy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; identical placebo once daily for 28 days
Active Comparator: Pantoprazole	Drug: Pantoprazole; 40 mg pantoprazole once daily for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To evaluate whether healthy volunteers, treated with PPI for four weeks, develop acid-related symptoms after cessation of PPI therapy.

Secondary Outcome Measures

Outcome Measure
To evaluate whether there is a correlation between markers for acid secretion such as gastrin and chromogranin-A and the development of dyspeptic symptoms.

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): October 1, 2006
• Study Completion (Actual): October 1, 2006

Study Registration Dates

• First Submitted: June 4, 2009
• First Submitted That Met QC Criteria: June 4, 2009
• First Posted (Estimate): June 5, 2009

Study Record Updates

• Last Update Posted (Estimate): June 5, 2009
• Last Update Submitted That Met QC Criteria: June 4, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: volunteers
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Pantoprazole
• Other Study ID Numbers: SUS/KUS2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No