Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2025-12-30 @ 3:40 AM
Study NCT ID:
NCT00384592
Status:
COMPLETED
Last Update Posted:
2009-03-11
First Post:
2006-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PPI Sequencing Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D006356', 'term': 'Heartburn'}], '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'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064098', 'term': 'Esomeprazole'}, {'id': 'D012149', 'term': 'Restraint, Physical'}], 'ancestors': [{'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-10', 'studyFirstSubmitDate': '2006-10-05', 'studyFirstSubmitQcDate': '2006-10-05', 'lastUpdatePostDateStruct': {'date': '2009-03-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective of this study is to assess the change in the frequency of heartburn from baseline value at entry to the end of the study, after 8-weeks treatment with esomeprazole 40mg compared to previous full dose treatment with a PPI daily'}], 'secondaryOutcomes': [{'measure': 'Change in frequency and severity of heartburn, epigastric pain and acid regurgitation after 4 and 8 weeks treatment from baseline value at study entry'}, {'measure': 'Change in symptom control from baseline to 4 and 8 weeks using QOL questionnaires'}]}, 'conditionsModule': {'keywords': ['heartburn', 'reflux', 'proton pump inhibitor', 'GERD', 'GORD'], 'conditions': ['Gastro-Oesophageal Reflux Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess how patients with gastro-oesophageal reflux disease (heartburn) who are currently receiving treatment with a proton pump inhibitor but are still experiencing symptoms will benefit from a change in treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persisting symptoms of GORD despite previous treatment with a full dose proton pump inhibitor\n* Informed consent\n* Over 18 years of age\n\nExclusion Criteria:\n\n* Current course of Proton Pump inhibitor treatment for more than 8 weeks prior to enrolment in the study;\n* More than 1 other course of PPI treatment in the previous 12 month;\n* Previous use of esomeprazole;\n* Presence of alarm symptoms.'}, 'identificationModule': {'nctId': 'NCT00384592', 'briefTitle': 'PPI Sequencing Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Study to Assess the Effectiveness of Esomeprazole 40 mg Once Daily in Subjects With Continuing Gastroesophageal Reflux Disease (GORD) Symptoms Following Treatment Wit a Previous Full Dose Proton Pump Inhibitor (PPI)', 'orgStudyIdInfo': {'id': 'D9612L00104'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Esomeprazole', 'type': 'DRUG'}, {'name': 'Physical exam', 'type': 'PROCEDURE'}, {'name': 'Pregnancy test if applicable', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Allerton', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.36697, 'lon': -2.894}}, {'city': 'Ashford', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.14648, 'lon': 0.87376}}, {'city': 'Atherstone', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.57536, 'lon': -1.54693}}, {'city': 'Ayrshire', 'country': 'United Kingdom', 'facility': 'Research Site'}, {'city': 'Bath', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.3751, 'lon': -2.36172}}, {'city': 'Blackpool', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.81667, 'lon': -3.05}}, {'city': 'Bolton', 'country': 'United Kingdom', 'facility': 'Research SIte', 'geoPoint': {'lat': 53.58333, 'lon': -2.43333}}, {'city': 'Coventry', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'city': 'Fowey', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 50.33634, 'lon': -4.6386}}, {'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Research SIte', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'Hamilton', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 55.76667, 'lon': -4.03333}}, {'city': 'Motherwell', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 55.78924, 'lon': -3.99187}}, {'city': 'Stevenage', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.90224, 'lon': -0.20256}}, {'city': 'Warminster', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.20434, 'lon': -2.17873}}], 'overallOfficials': [{'name': 'Rhiannon Rowsell, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}, {'name': 'Roger Jones, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}