Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT01130935
Status:
COMPLETED
Last Update Posted:
2011-02-24
First Post:
2010-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Survey Examining the Frequency and Severity of Acid Related Symptoms While Taking Nexium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D004381', 'term': 'Duodenal Ulcer'}], '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': 'D010437', 'term': 'Peptic Ulcer'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 491}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-23', 'studyFirstSubmitDate': '2010-05-20', 'studyFirstSubmitQcDate': '2010-05-25', 'lastUpdatePostDateStruct': {'date': '2011-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week.", 'timeFrame': 'Day 0'}, {'measure': "Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week.", 'timeFrame': 'Week 2-4'}, {'measure': "Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week.", 'timeFrame': 'Weeks 8-12'}], 'secondaryOutcomes': [{'measure': 'To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms.', 'timeFrame': 'Day 0'}, {'measure': 'Evaluate with which treatment regimen and on which indications acid suppression with isomeric proton pump inhibitor is used in routine clinical practice in Albania.', 'timeFrame': 'Once: Day 0'}, {'measure': 'Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events.', 'timeFrame': 'Day 0'}, {'measure': 'To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms.', 'timeFrame': 'Weeks 2-4'}, {'measure': 'To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms.', 'timeFrame': 'Weeks 8-12'}, {'measure': 'Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events.', 'timeFrame': 'Weeks 2-4'}, {'measure': 'Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events.', 'timeFrame': 'Weeks 8-12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GERD', 'gastric and duodenal ulcers', 'NSAID therapy'], 'conditions': ['Gastric Acid Suppression', 'Proton Pump Inhibitors']}, 'descriptionModule': {'briefSummary': 'This study will assess the effectiveness of Nexium at alleviating upper GI symptoms in subjects and evaluate with which treatment regimen and on which indications acid suppression with isomeric proton pump inhibitor is used in routine clinical practice in Albania.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Male or female subjects, age \\> 18 years, having had upper GI symptoms requiring acid suppression treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must have had upper GI symptoms requiring acid suppression treatment\n* Treatment with Nexium is in accordance with indications and dosing approved in Albania.\n* Start of treatment at least 2 weeks prior to enrollment to this study 5. Written informed consent is signed.\n\nExclusion Criteria:\n\n* Known hypersensitivity to Nexium or any other constituents of the formulation\n* Concomitant administration of atazanavir and nelfinavir.\n* Alarming upper GI symptoms (i.e. significant unintended weight loss, vomiting, dysphasia, hematemesis, melena, fever, jaundice or any other sign indicating serious or malignant disease'}, 'identificationModule': {'nctId': 'NCT01130935', 'briefTitle': 'Survey Examining the Frequency and Severity of Acid Related Symptoms While Taking Nexium', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A National, Multicentre, Open-label, Non-comparative, Non-interventional Survey Examining the Frequency and Severity of Acid Related Symptoms While Taking Nexium', 'orgStudyIdInfo': {'id': 'NIS-GAL-NEX-2010/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berat', 'country': 'Albania', 'facility': 'Research Site', 'geoPoint': {'lat': 40.70583, 'lon': 19.95222}}, {'city': 'Burrel', 'country': 'Albania', 'facility': 'Research Site', 'geoPoint': {'lat': 41.61028, 'lon': 20.00889}}, {'city': 'Durrës', 'country': 'Albania', 'facility': 'Research Site', 'geoPoint': {'lat': 41.32355, 'lon': 19.45469}}, {'city': 'Elbasan', 'country': 'Albania', 'facility': 'Research Site', 'geoPoint': {'lat': 41.11138, 'lon': 20.08224}}, {'city': 'Fier', 'country': 'Albania', 'facility': 'Research Site', 'geoPoint': {'lat': 40.7251, 'lon': 19.55823}}, {'city': 'Kavajë', 'country': 'Albania', 'facility': 'Research Site', 'geoPoint': {'lat': 41.18556, 'lon': 19.55694}}, {'city': 'Korçë', 'country': 'Albania', 'facility': 'Research Site', 'geoPoint': {'lat': 40.61861, 'lon': 20.78083}}, {'city': 'Krujë', 'country': 'Albania', 'facility': 'Research Site', 'geoPoint': {'lat': 41.50917, 'lon': 19.79278}}, {'city': 'Lezhë', 'country': 'Albania', 'facility': 'Research Site', 'geoPoint': {'lat': 41.78361, 'lon': 19.64361}}, {'city': 'Lushnjë', 'country': 'Albania', 'facility': 'Research Site', 'geoPoint': {'lat': 40.94194, 'lon': 19.705}}, {'city': 'Peshkopi', 'country': 'Albania', 'facility': 'Research Site', 'geoPoint': {'lat': 41.685, 'lon': 20.42858}}, {'city': 'Shkodër', 'country': 'Albania', 'facility': 'Research Site', 'geoPoint': {'lat': 42.06828, 'lon': 19.51258}}, {'city': 'Tirana', 'country': 'Albania', 'facility': 'Research Site', 'geoPoint': {'lat': 41.32744, 'lon': 19.81866}}, {'city': 'Vlorë', 'country': 'Albania', 'facility': 'Research Site', 'geoPoint': {'lat': 40.4696, 'lon': 19.48379}}], 'overallOfficials': [{'name': 'Karin Otter, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical Director BBC'}, {'name': 'Senka Riza', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical and Regulatory Manager'}, {'name': 'Skerdi Prifti, Asc.Proff.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Center "Mother Teresa"'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'MC MD', 'oldOrganization': 'AstraZeneca Albania'}}}}