- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00061724
Medical and Surgical Treatment of Esophageal Reflux
January 12, 2010 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The purpose of this project is to lay the groundwork for a proposed clinical trial to compare the effectiveness of two approaches to gastroesophageal reflux disease: treatment with medications and treatment with anti-reflux surgery.
This project includes a non-interventional pilot study to test ways of measuring outcomes of treatment, and to gauge potential participants' willingness to enroll in the proposed clinical trial.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
175
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Maywood, Illinois, United States
- Hines VA Medical Center
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Dartmouth-Hitchcock Medical Center
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- age 18-80
- diagnosis of gastroesophageal reflux disease
- have taken proton pump inhibitor medications
Exclusion criteria:
- prior esophageal surgery
- other serious medical conditions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
June 3, 2003
First Submitted That Met QC Criteria
June 3, 2003
First Posted (Estimate)
June 4, 2003
Study Record Updates
Last Update Posted (Estimate)
January 13, 2010
Last Update Submitted That Met QC Criteria
January 12, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSTER (completed)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gastroesophageal Reflux
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GlaxoSmithKlineCompletedReflux, Gastroesophageal | Gastroesophageal Reflux DiseaseAustralia
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Onconic Therapeutics Inc.Not yet recruitingNon-erosive Gastroesophageal Reflux Disease
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University of North Carolina, Chapel HillNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedGastroesophageal Reflux Disease | GERD | Acid Reflux | RefluxUnited States
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I.M. Sechenov First Moscow State Medical UniversityActive, not recruitingGastroesophageal Reflux Disease (GERD) | Non-Erosive Gastro-Esophageal Reflux DiseaseRussia
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Ying ZhuNot yet recruitingGastroesophageal Reflux Disease (GERD)China
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Daewon Pharmaceutical Co., Ltd.CompletedGERD (Gastroesophageal Reflux Disease)South Korea
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Ezisurg Medical Co. Ltd.University Hospital, MontpellierCompletedGastroesophageal Reflux Disease (GERD)France
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Cinclus Pharma Holding ABWithdrawn
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GlaxoSmithKlineCompletedReflux, Gastroesophageal | Gastroesophageal Reflux DiseaseAustralia
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TakedaTerminatedGastroesophageal Reflux Disease | Non-erosive Reflux DiseaseSwitzerland, Netherlands