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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 6, 2008 | ||||
| Last Updated Date | March 4, 2009 | ||||
| Start Date ICMJE | May 2004 | ||||
| Estimated Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The primary aim of the study is to establish that patients with symptoms of LPR who are referred to an otolaryngology clinic have a prevalence of Barrett's metaplasia equivalent to that of a population with GERD symptoms. [ Time Frame: One time ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00695227 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Screening for Barrett's Esophagus in Otolaryngology Patients | ||||
| Official Title ICMJE | Screening for Barrett's Esophagus in Otolaryngology Patients | ||||
| Brief Summary | The purpose of this project is to develop an accurate method to identify patients that suffer from acid reflux, but may not present with classic reflux symptoms (such as heart burn). Additionally, it is the purpose of this project to utilize the Unsedated Small-caliber Endoscopy (USE) to assess the prevalence of Barrett's esophagus in a population of patients with laryngopharyngeal reflux (LPR) symptoms and to define normal patterns of LPR. Laryngopharyngeal reflux (LPR) is when a small amount of stomach contents and acid are pushed up through the esophagus and may affect the vocal cords and upper respiratory tract. It is suspected that patients with LPR symptoms may have a prevalence of Barrett's esophagus similar to that found in a population with typical reflux symptoms. We propose to systematically test this hypothesis using the USE. This project is designed to improve the methods of identifying patients with a form of acid reflux that is often undetected, and thus untreated. If this project is successful then more patients with Barrett's esophagus will be identified; furthermore, screening and treatment for this pre-cancerous condition will be improved. |
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| Detailed Description | |||||
| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Proton Pump Inhibitor | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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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 | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 500 | ||||
| Estimated Completion Date | November 2012 | ||||
| Estimated Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: - Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 90 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 | NCT00695227 | ||||
| Responsible Party | Joshua Schindler, Oregon Health & Science University | ||||
| Study ID Numbers ICMJE | DK66165, DK066165-02 | ||||
| Study Sponsor ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||
| Verification Date | March 2009 | ||||
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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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