Symptom Evaluation After Cessation of a Proton Pump Inhibitor in Healthy Volunteers - Full Text View

Sponsored by:	Sahlgrenska University Hospital, Sweden
Information provided by:	Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:	NCT00915239

Purpose

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	Intervention
Healthy	Drug: Pantoprazole Drug: Placebo

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	Symptom Evaluation After Cessation of a Proton Pump Inhibitor in Healthy Volunteers

Resource links provided by NLM:

Drug Information available for: Pantoprazole Pantoprazole Sodium

U.S. FDA Resources

Further study details as provided by Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:

To evaluate whether healthy volunteers, treated with PPI for four weeks, develop acid-related symptoms after cessation of PPI therapy. [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Enrollment:	50
Study Start Date:	January 2006
Study Completion Date:	October 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Pantoprazole: Active Comparator	Drug: Pantoprazole 40 mg pantoprazole once daily for 28 days
Placebo: Placebo Comparator	Drug: Placebo identical placebo once daily for 28 days

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).

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00915239

Locations

Sweden
Sahlgrenska Univeristy Hospital
Gothenburg, Sweden, 413 45

Sponsors and Collaborators

Sahlgrenska University Hospital, Sweden

More Information

No publications provided

Responsible Party:	Sahlgrenska University Hospital ( Einar Björnsson )
Study ID Numbers:	SUS/KUS2
Study First Received:	June 4, 2009
Last Updated:	June 4, 2009
ClinicalTrials.gov Identifier:	NCT00915239 History of Changes
Health Authority:	Sweden: Regional Ethical Review Board; Sweden: Medical Products Agency

Keywords provided by Sahlgrenska University Hospital, Sweden:

volunteers

Study placed in the following topic categories:

Proton Pump Inhibitors
Pantoprazole
Healthy

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Proton Pump Inhibitors
Therapeutic Uses
Pantoprazole

Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 03, 2009