Symptom Evaluation After Cessation of a Proton Pump Inhibitor in Healthy Volunteers
Overview[ - collapse ][ - ]
| 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 | Healthy |
| Intervention | Drug: Pantoprazole Drug: Placebo |
| Phase | N/A |
| Sponsor | Sahlgrenska University Hospital, Sweden |
| Responsible Party | Sahlgrenska University Hospital, Sweden |
| ClinicalTrials.gov Identifier | NCT00915239 |
| First Received | June 4, 2009 |
| Last Updated | June 4, 2009 |
| Last verified | June 2009 |
Tracking Information[ + expand ][ + ]
| First Received Date | June 4, 2009 |
|---|---|
| Last Updated Date | June 4, 2009 |
| Start Date | January 2006 |
| Estimated Primary Completion Date | October 2006 |
| Current 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] |
| Current 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. |
Descriptive Information[ + expand ][ + ]
| Brief Title | Symptom Evaluation After Cessation of a Proton Pump Inhibitor in Healthy Volunteers |
|---|---|
| Official Title | Symptom Evaluation After Cessation of a Proton Pump Inhibitor in Healthy Volunteers |
| 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. |
| 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 |
| Study Phase | N/A |
| Study Design | Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Basic Science |
| Condition | Healthy |
| Intervention | Drug: Pantoprazole 40 mg pantoprazole once daily for 28 days Drug: Placebo identical placebo once daily for 28 days |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 50 |
| Estimated Completion Date | October 2006 |
| Estimated Primary Completion Date | October 2006 |
| Eligibility 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | Sweden |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00915239 |
|---|---|
| Other Study ID Numbers | SUS/KUS2 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Sahlgrenska University Hospital, Sweden |
| Study Sponsor | Sahlgrenska University Hospital, Sweden |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | June 2009 |
Locations[ + expand ][ + ]
| Sahlgrenska Univeristy Hospital | Gothenburg, Sweden, 413 45 |
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