Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT00795093
Status:
COMPLETED
Last Update Posted:
2010-05-11
First Post:
2008-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Partial Response to Proton Pump Inhibitors (PPI) Treatment: The Cost to Society and the Burden to the Patient - a Study in the US
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 552}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-10', 'studyFirstSubmitDate': '2008-11-20', 'studyFirstSubmitQcDate': '2008-11-20', 'lastUpdatePostDateStruct': {'date': '2010-05-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life, productivity loss, frequency and severity of GERD symptoms, health care resource use', 'timeFrame': 'Collected at enrollment visit and at 3 and 6 month follow-up. (Health care resource use is at enrollment visit collected retrospectively 6 months)'}, {'measure': 'Utility values', 'timeFrame': 'Collected at enrollment visit and at 6 month follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GERD', 'PPI', 'partial responders'], 'conditions': ['Gastroesophageal Reflux Disease (GERD)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to describe common treatment pathways, to collect health care utilization data and to assess symptom load as well as impact of symptoms on daily life in GERD patients who are partial-responders to PPI treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Gastroesophageal Reflux Disease (GERD) classified as partial responders to proton pump inhibitors (PPIs).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 6 month history of GERD symptoms\n* Treated with unchanged optimized PPI treatment for any GERD indication during a consecutive 4 week period\n* Remaining GERD symptoms despite optimized PPI treatment\n* Able to read and write in US English, and able to comply with study requirements\n\nExclusion Criteria:\n\n* Patients that have not experienced any GERD symptom improvement at all during PPI treatment\n* Involvement in the planning or conduct of the study\n* Involvement in any other observational study or in any clinical study at the time of this study or during the last 6 months'}, 'identificationModule': {'nctId': 'NCT00795093', 'acronym': 'REMAIN', 'briefTitle': 'Partial Response to Proton Pump Inhibitors (PPI) Treatment: The Cost to Society and the Burden to the Patient - a Study in the US', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Partial Response to PPI Treatment: The Cost to Society and the Burden to the Patient', 'orgStudyIdInfo': {'id': 'D9120N00005'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': '552 GERD patients, partial responders to PPI treatment'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leeds', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.54816, 'lon': -86.54443}}, {'city': 'Pheonix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site'}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'city': 'Lancaster', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.69804, 'lon': -118.13674}}, {'city': 'Los Banos', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.05828, 'lon': -120.84992}}, {'city': 'Solana Beach', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.99115, 'lon': -117.27115}}, {'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'city': 'Altamonte Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.66111, 'lon': -81.36562}}, {'city': 'Cocoa', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.38612, 'lon': -80.742}}, {'city': 'DeFuniak Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.72102, 'lon': -86.11522}}, {'city': 'Largo', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 27.90979, 'lon': -82.78842}}, {'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Palm Harbor', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.07807, 'lon': -82.76371}}, {'city': 'Peonia', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site'}, {'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'city': 'Roswell', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.02316, 'lon': -84.36159}}, {'city': 'Royston', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.28705, 'lon': -83.11015}}, {'city': 'Snellville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.85733, 'lon': -84.01991}}, {'city': 'Belleville', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.52005, 'lon': -89.98399}}, {'city': 'Mishawaka', 'state': 'Indiana', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.66199, 'lon': -86.15862}}, {'city': 'Metaire', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Research Site'}, {'city': 'Prince Frederick', 'state': 'Maryland', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.5404, 'lon': -76.5844}}, {'city': 'Towson', 'state': 'Maryland', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.4015, 'lon': -76.60191}}, {'city': 'Florissant', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.78922, 'lon': -90.32261}}, {'city': 'Jefferson City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.5767, 'lon': -92.17352}}, {'city': 'Atco', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.76984, 'lon': -74.88739}}, {'city': 'Fair Lawn', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.94038, 'lon': -74.13181}}, {'city': 'Cary', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.79154, 'lon': -78.78112}}, {'city': 'Elkin', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.2443, 'lon': -80.8484}}, {'city': 'New Bern', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.10849, 'lon': -77.04411}}, {'city': 'Stanley', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.35903, 'lon': -81.09702}}, {'city': 'Statesville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.78264, 'lon': -80.8873}}, {'city': 'Beachwood', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.4645, 'lon': -81.50873}}, {'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'city': 'Vandalia', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.89061, 'lon': -84.19883}}, {'city': 'Aliquippa', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.63673, 'lon': -80.24006}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'city': 'Athens', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.44285, 'lon': -84.59299}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Irving', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.81402, 'lon': -96.94889}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'San Marcos', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.88327, 'lon': -97.94139}}, {'city': 'Southlake', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.94124, 'lon': -97.13418}}, {'city': 'West Jordan', 'state': 'Utah', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.60967, 'lon': -111.9391}}], 'overallOfficials': [{'name': 'Meg Good', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'i3 Innovus'}, {'name': 'Marie Sundin', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'i3 Innovus', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Debra Silberg, MD PhD, Medical Science Director, Clinical Research', 'oldOrganization': 'AstraZeneca R&D'}}}}