Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-03-03 @ 5:17 AM
Study NCT ID:
NCT00641602
Status:
COMPLETED
Last Update Posted:
2009-03-26
First Post:
2008-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter, Randomized, Double Blind, Double Dummy, Parallel-Group Efficacy Study Comparing 8 Weeks of Treatment With Esomeprazole Magnesium (40mg qd) to Lansoprazole (30mg qd) for the Healing of Erosive Esophagitis in Patients With Moderate or Severe Erosive Esophagitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006356', 'term': 'Heartburn'}], 'ancestors': [{'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': 'D064747', 'term': 'Lansoprazole'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2003-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-25', 'studyFirstSubmitDate': '2008-03-18', 'studyFirstSubmitQcDate': '2008-03-21', 'lastUpdatePostDateStruct': {'date': '2009-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the difference in healing rates of erosive esophagitis (EE) between esomeprazole 40 mg qd (E40) and lansoprazole 30 mg qd (L30) in patients with moderate or severe EE, defined as Grade C or D in the Los Angeles (LA) Classification scale.', 'timeFrame': 'Esophagogastroduodenoscopy (EGD) at baseline and then week 4 and week 8 (if not healed at week 4)'}], 'secondaryOutcomes': [{'measure': '1. To compare the difference in the resolution of, and relief of, the investigator evaluated GERD symptoms of heartburn, acid regurgitation, dysphagia, and epigastric pain between E40 and L30 at week 4 of treatment in patients with moderate or severe EE.', 'timeFrame': 'Esophagogastroduodenoscopy (EGD) at baseline and then week 4 and week 8 (if not healed at week 4)'}, {'measure': "1. To compare the difference between E40 and L30 in the occurrence of heartburn symptoms as reported in the patient's daily diary.", 'timeFrame': 'Dairy card to be completed by patient daily'}, {'measure': 'To evaluate safety and tolerability of E40 compared to that of L30 in patients with moderate or severe EE.', 'timeFrame': 'Adverse event collection on an ongoing basis'}]}, 'conditionsModule': {'keywords': ['Erosive Esophagitis', 'Nexium', 'Heartburn'], 'conditions': ['Erosive Esophagitis']}, 'descriptionModule': {'briefSummary': 'This study looks at the healing rates in patients with Erosive Esophagitis (EE) when treated with either esomeprazole or lansoprazole'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Episodes of heartburn (described as a burning feeling, rising from the stomach or lower part of the chest up towards the neck) for 2 days or more during the last 7 days prior to baseline.\n* Confirmed Erosive Esophagitis within 1 week prior to starting the study.\n\nExclusion Criteria:\n\n* Any signs of gastrointestinal bleeding at the time of the starting the study.\n* Any previous gastric or esophageal surgery.\n* Various gastrointestinal diseases as listed in the protocol.'}, 'identificationModule': {'nctId': 'NCT00641602', 'briefTitle': 'A Multicenter, Randomized, Double Blind, Double Dummy, Parallel-Group Efficacy Study Comparing 8 Weeks of Treatment With Esomeprazole Magnesium (40mg qd) to Lansoprazole (30mg qd) for the Healing of Erosive Esophagitis in Patients With Moderate or Severe Erosive Esophagitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Multicenter, Randomized, Double Blind, Double Dummy, Parallel-Group Efficacy Study Comparing 8 Weeks of Treatment With Esomeprazole Magnesium (40mg qd) to Lansoprazole (30mg qd) for the Healing of Erosive Esophagitis in Patients With Moderate or Severe Erosive Esophagitis.', 'orgStudyIdInfo': {'id': '322'}, 'secondaryIdInfos': [{'id': 'D9612L00046'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Nexium', 'interventionNames': ['Drug: Esomeprazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Prevacid', 'interventionNames': ['Drug: Lansoprazole']}], 'interventions': [{'name': 'Esomeprazole', 'type': 'DRUG', 'otherNames': ['Nexium'], 'description': '40mg once daily', 'armGroupLabels': ['1']}, {'name': 'Lansoprazole', 'type': 'DRUG', 'otherNames': ['Prevacid'], 'description': '30mg once daily', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Paula Fernstrom', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nexium Global Product Director, AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Tore Lind, MD - Nexium Medical Science Director', 'oldOrganization': 'Astra Zeneca'}}}}