Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-03-05 @ 11:30 PM
Study NCT ID:
NCT04094402
Status:
UNKNOWN
Last Update Posted:
2019-09-23
First Post:
2019-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epi-GERD Study: Epidemiological Evaluation in Patients With Gastro-Esophageal Reflux Disease (GERD)
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': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-20', 'studyFirstSubmitDate': '2019-09-16', 'studyFirstSubmitQcDate': '2019-09-17', 'lastUpdatePostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptoms of GERD (Gastroesophageal Reflux Disease)', 'timeFrame': 'It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years', 'description': 'Proportion of patients with persistence and / or relapse of symptoms of GERD.'}], 'secondaryOutcomes': [{'measure': 'Demographic analysis', 'timeFrame': 'It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years', 'description': 'Characterization of patients'}, {'measure': 'Kind of IBP taked by the patient and the way to consume it.', 'timeFrame': 'It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years', 'description': 'A descriptive analysis of the type of IBP types taken by patients and how to take them'}, {'measure': 'Adverse Events related with the treatments', 'timeFrame': 'It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years', 'description': 'Evaluation of Adverse events associated with the treatment (s)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastroesophageal Reflux Disease']}, 'descriptionModule': {'briefSummary': 'Cross-sectional epidemiological study in patients with diagnosis of GERD (Gastroesophageal Reflux Disease) and with current treatment or with a history of recent treatment with some PPI (Proton Pump Inhibitor), in order to evaluate the persistence and / or relapse of symptoms of GERD.', 'detailedDescription': 'OBJECTIVE: To carry out an evaluation about the persistence and / or relapse of symptoms in Colombian patients with diagnosis of GERD.\n\nMATERIALS AND METHODS: A multicentric cross-sectional epidemiological study will be carried out in Colombian patients with diagnosis of GERD and with current treatment or with a history of recent treatment with some PPI (Proton Pump Inhibitor). The persistence and / or relapse of symptoms will be evaluated as the main variable. The secondary variables to be evaluated include: Demographical analysis, treatment (s) used by patients, adverse events associated with the treatments, comorbidities and risk factors. The analysis will be carried out from two perspectives: A first descriptive approach and a second analytical approach, with a level of significance of 5%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients ≥ 18 years, with previous diagnosis of Gastroesophageal Reflux Disease (GERD)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Previous diagnosis of Gastroesophageal Reflux Disease (GERD)\n* CURRENT treatment with a proton-pump inhibitor (PPI), OR NOT CURRENT treatment with some PPI but YES in the last year\n\nExclusion Criteria:\n\n* Refusal to participate in the study by the patient.\n* Patients who, in the judgment of the Investigator, do not understand or are not willing to adequately answer to the questions.\n* Mental or psychiatric illness that, in the judgment of the investigator, does not allow adequate information to be obtained.'}, 'identificationModule': {'nctId': 'NCT04094402', 'acronym': 'Epi-ERGE', 'briefTitle': 'Epi-GERD Study: Epidemiological Evaluation in Patients With Gastro-Esophageal Reflux Disease (GERD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Scandinavia Pharma'}, 'officialTitle': 'Epi-GERD Study: Epidemiological Evaluation in Patients With Gastro-Esophageal Reflux', 'orgStudyIdInfo': {'id': 'Epi-ERGE'}}, 'armsInterventionsModule': {'interventions': [{'name': 'None. It is an observational study', 'type': 'OTHER', 'description': 'None. It is an observational study'}]}, 'contactsLocationsModule': {'locations': [{'zip': '110111', 'city': 'Bogotá', 'status': 'RECRUITING', 'country': 'Colombia', 'contacts': [{'name': 'Javier Castillo, Dr', 'role': 'CONTACT'}], 'facility': 'Scandinavia Pharma', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}], 'centralContacts': [{'name': 'Javier Castillo, Dr', 'role': 'CONTACT', 'email': 'jcastill@scandinavia.com.co', 'phone': '+571-6461700'}, {'name': 'Ferrari Claudio, Dr', 'role': 'CONTACT', 'email': 'cferrari@scandinavia.com.co', 'phone': '+571-6461700'}], 'overallOfficials': [{'name': 'Javier Castillo, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical Director'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scandinavia Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}