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| Tracking Information | |||||
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| First Received Date ICMJE | June 12, 2006 | ||||
| Last Updated Date | July 20, 2007 | ||||
| Start Date ICMJE | April 2006 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Compare change in gastric acid output in response to an 11-day course of daily cinacalcet or placebo in subjects on a fixed protein metabolic diet. [ Time Frame: 11 days ] | ||||
| Original Primary Outcome Measures ICMJE |
Compare change in gastric acid output in response to an 11-day course of daily cinacalcet or placebo in subjects on a fixed protein metabolic diet. | ||||
| Change History | Complete list of historical versions of study NCT00336739 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | The Effect of Cinacalcet on Gastric Acid Output in Healthy Subjects | ||||
| Official Title ICMJE | |||||
| Brief Summary | The purpose of this study is to determine whether cinacalcet will increase gastric acid secretion in healthy volunteers. |
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| Detailed Description | The calcium sensing receptor (CaSR) was originally found on parathyroid and renal cells and more recently it has been identified on cells that regulate gastric acid secretion (G cells and parietal cells). However, its role in regulating acid secretion in humans is completely unknown and is of potential importance because an acid environment in the stomach enhances intestinal calcium absorption. In this pilot project, we will stimulate the CaSR with a CaSR-agonist called cinacalcet. Our hypothesis is that activation of the CaSR will in turn increase gastric acid production in healthy volunteers. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Diagnostic, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacodynamics Study | ||||
| Condition ICMJE | Healthy | ||||
| Intervention ICMJE | Drug: cinacalcet | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | Ceglia L, Harris SS, Rasmussen HM, Dawson-Hughes B. Activation of the calcium sensing receptor stimulates gastrin and gastric acid secretion in healthy participants. Osteoporos Int. 2009 Jan;20(1):71-8. Epub 2008 Jun 7. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 17 | ||||
| Completion Date | March 2007 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Exclusion Diseases
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| Gender | Both | ||||
| Ages | 45 Years to 70 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00336739 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 2455 | ||||
| Study Sponsor ICMJE | Tufts University | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Tufts University | ||||
| Verification Date | June 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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