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

This study has been completed.
Sponsor:
Information provided by:
Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT00915239
First received: June 4, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Basic Science
Official Title: Symptom Evaluation After Cessation of a Proton Pump Inhibitor in Healthy Volunteers

Resource links provided by NLM:


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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by Sahlgrenska University Hospital, Sweden:
volunteers

Additional relevant MeSH terms:
Pantoprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014