Effect of Coffee on Gastro-Esophageal Disease in Patients With Symptoms of Reflux
This study has been completed.
Sponsor:
University of California, Davis
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00584259
First received: December 26, 2007
Last updated: July 12, 2010
Last verified: July 2010
| Tracking Information | |||||
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| First Received Date ICMJE | December 26, 2007 | ||||
| Last Updated Date | July 12, 2010 | ||||
| Start Date ICMJE | May 2006 | ||||
| Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
coffee leads to reflux events [ Time Frame: 48 hours ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00584259 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Coffee on Gastro-Esophageal Disease in Patients With Symptoms of Reflux | ||||
| Official Title ICMJE | Effect of Coffee on Gastro-Esophageal Disease in Patients With Symptoms of Reflux | ||||
| Brief Summary | Investigation evaluating the effect of coffee on gastro-esophageal reflux disease. |
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| Detailed Description | Many patients with gastro-esophageal reflux disease (GERD) report that drinking coffee causes heartburn. The purpose of this study is to investigate the effects of coffee on gastro-esophageal acid reflux, and its relation to esophageal motility parameters in patients who are already scheduled to undergo 48 hour wireless pH testing as a result of having symptoms suggestive of GERD. The specific aims are to evaluate the effects of coffee on GERD during daily life and to elucidate the underlying pathogenic mechanism by which coffee induces reflux. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | GERD | ||||
| Intervention ICMJE | Other: Coffee
3 cups of coffee over a 24 hour period |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 7 | ||||
| Completion Date | January 2010 | ||||
| Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00584259 | ||||
| Other Study ID Numbers ICMJE | 200614348-2 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Peter Belafsky, MD, Ph.D., University of California Davis | ||||
| Study Sponsor ICMJE | University of California, Davis | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of California, Davis | ||||
| Verification Date | July 2010 | ||||
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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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