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

June 4, 2009
June 4, 2009
January 2006
October 2006   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
To evaluate whether there is a correlation between markers for acid secretion such as gastrin and chromogranin-A and the development of dyspeptic symptoms.
Same as current
Not Provided
Not Provided
 
Symptom Evaluation After Cessation of a Proton Pump Inhibitor in Healthy Volunteers
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.

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).

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Basic Science
Healthy
  • Drug: Pantoprazole
    40 mg pantoprazole once daily for 28 days
  • Drug: Placebo
    identical placebo once daily for 28 days
  • Active Comparator: Pantoprazole
    Intervention: Drug: Pantoprazole
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
October 2006
October 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00915239
SUS/KUS2
Yes
Einar Björnsson, Sahlgrenska University Hospital
Sahlgrenska University Hospital, Sweden
Not Provided
Not Provided
Sahlgrenska University Hospital, Sweden
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP