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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00695227 |
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.
Condition | Intervention | Phase |
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Extra Esophageal Symptoms: Cough Throat Clearing Hoarseness Difficulty Swallowing |
Drug: Proton Pump Inhibitor |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Screening for Barrett's Esophagus in Otolaryngology Patients |
Estimated Enrollment: | 500 |
Study Start Date: | May 2004 |
Estimated Study Completion Date: | November 2013 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
-
Exclusion Criteria:
United States, Oregon | |
Oregon Health & Science University | Recruiting |
Portland, Oregon, United States, 97239-3098 | |
Contact: Stevie Jepsen, BS 503-494-8164 | |
Principal Investigator: Joshua Schindler, MD |
Principal Investigator: | Joshua Schindler, MD | Oregon Health and Science University |
Responsible Party: | Oregon Health & Science University ( Joshua Schindler ) |
Study ID Numbers: | DK66165, DK066165-02 |
Study First Received: | June 6, 2008 |
Last Updated: | December 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00695227 |
Health Authority: | United States: Food and Drug Administration; United States: Federal Government |
laryngopharyngeal reflux extraesophageal reflux symptoms |
Otorhinolaryngologic Diseases Esophageal disorder Gastrointestinal Diseases Hoarseness Respiration Disorders Cough Pharyngeal Diseases Deglutition Disorders Signs and Symptoms Digestive System Abnormalities |
Digestive System Diseases Respiratory Tract Diseases Signs and Symptoms, Respiratory Neurologic Manifestations Barrett Esophagus Esophageal Diseases Voice Disorders Laryngeal Diseases Congenital Abnormalities |
Nervous System Diseases |