Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 10:00 PM
Study NCT ID:
NCT01039558
Status:
COMPLETED
Last Update Posted:
2011-07-28
First Post:
2009-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Lansoprazole in Combination With Ecabet Sodium for Gastroesophageal Reflux Disease
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C061681', 'term': 'ecabet'}, {'id': 'D064747', 'term': 'Lansoprazole'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-27', 'studyFirstSubmitDate': '2009-12-23', 'studyFirstSubmitQcDate': '2009-12-24', 'lastUpdatePostDateStruct': {'date': '2011-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'We will compare the summations of symptoms score and calculate the response rate', 'timeFrame': 'after 4 weeks and 8 weeks'}], 'secondaryOutcomes': [{'measure': 'the global response of treatment', 'timeFrame': 'after 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['gastroesophageal reflux disease', 'lansoprazole', 'ecabet sodium'], 'conditions': ['Gastroesophageal Reflux Disease']}, 'descriptionModule': {'briefSummary': 'We will estimate the responses of lansoprazole and ecabet sodium combination therapy and compare with lansoprazole and placebo therapy in patients who need additional therapy after standard proton pump inhibitor treatment for 4week or more in recurrent gastroesophageal reflux disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 19-75 years\n* patients with typical gastroesophageal symptom or erosive reflux esophagitis on gastroduodenoscopy\n* patients with recurrent gastroesophageal symptom after standard proton pump inhibitor treatment for 4 weeks or more\n\nExclusion Criteria:\n\n* patients with gastric ulcer or duodenal ulcer\n* patients with gastric cancer or esophageal cancer\n* pregnant or postpartum women'}, 'identificationModule': {'nctId': 'NCT01039558', 'briefTitle': 'The Effect of Lansoprazole in Combination With Ecabet Sodium for Gastroesophageal Reflux Disease', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Randomized Controlled Trial to Evaluate the Effect of Lansoprazole in Combination With Ecabet Sodium for Gastroesophageal Reflux Disease', 'orgStudyIdInfo': {'id': 'RECURRENT GERD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'lansoprazole + ecabet sodium', 'interventionNames': ['Drug: ecabet sodium', 'Drug: lansoprazole']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'lansoprazole + placebo', 'interventionNames': ['Drug: lansoprazole', 'Drug: placebo']}], 'interventions': [{'name': 'ecabet sodium', 'type': 'DRUG', 'otherNames': ['Gastrex ganules'], 'description': 'Active comparator group patients will take lansoprazole 15 mg once daily and ecabet sodium 1.0 g three times daily and placebo group patients will take lansoprazole 15 mg once daily and placebo 1.0 g three times daily for total 8 weeks.', 'armGroupLabels': ['lansoprazole + ecabet sodium']}, {'name': 'lansoprazole', 'type': 'DRUG', 'description': 'Active comparator group patients will take lansoprazole 15 mg once daily and ecabet sodium 1.0 g three times daily and placebo group patients will take lansoprazole 15 mg once daily and placebo 1.0 g three times daily for total 8 weeks.', 'armGroupLabels': ['lansoprazole + ecabet sodium', 'lansoprazole + placebo']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Active comparator group patients will take lansoprazole 15 mg once daily and ecabet sodium 1.0 g three times daily and placebo group patients will take lansoprazole 15 mg once daily and placebo 1.0 g three times daily for total 8 weeks.', 'armGroupLabels': ['lansoprazole + placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Joo Sung Kim, M.D., PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Joo Sung Kim', 'oldOrganization': 'Seoul National University Hospital'}}}}