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Completed

NCT Number: NCT00915239

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.

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Key information

Conditions

Healthy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska Univeristy Hospital

Gothenburg, 413 45, Sweden

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pantoprazole

Drug

40 mg pantoprazole once daily for 28 days

Placebo

Drug

identical placebo once daily for 28 days

Primary outcomes

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Jun 5, 2009
Registry last updated
Jun 5, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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