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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00915239
Recruitment Status : Completed
First Posted : June 5, 2009
Last Update Posted : June 5, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Pantoprazole Drug: Placebo Not Applicable

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  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Basic Science
Official Title: Symptom Evaluation After Cessation of a Proton Pump Inhibitor in Healthy Volunteers
Study Start Date : January 2006
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Pantoprazole Drug: Pantoprazole
40 mg pantoprazole once daily for 28 days
Placebo Comparator: Placebo Drug: Placebo
identical placebo once daily for 28 days

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

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

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00915239

Sahlgrenska Univeristy Hospital
Gothenburg, Sweden, 413 45
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden

Responsible Party: Einar Björnsson, Sahlgrenska University Hospital Identifier: NCT00915239     History of Changes
Other Study ID Numbers: SUS/KUS2
First Posted: June 5, 2009    Key Record Dates
Last Update Posted: June 5, 2009
Last Verified: June 2009

Keywords provided by Sahlgrenska University Hospital, Sweden:

Additional relevant MeSH terms:
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action