Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT00701259
Status:
COMPLETED
Last Update Posted:
2010-01-15
First Post:
2008-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy/Safety of Lansoprazole in Patients With Frequent Nighttime Heartburn
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 852}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-13', 'studyFirstSubmitDate': '2008-06-17', 'studyFirstSubmitQcDate': '2008-06-18', 'lastUpdatePostDateStruct': {'date': '2010-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of nighttimes with no heartburn during 14 days of double-blind treatment in subjects with frequent heartburn.', 'timeFrame': '14 days'}], 'secondaryOutcomes': [{'measure': 'Proportion of 24 hour days with no heartburn during 14 days of treatment. Proportion of subjects with no heartburn during day 1 (the 24 hours following the first dose. The evaluation of lansoprazole safety.', 'timeFrame': '14 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Frequent heartburn, proton pump inhibitor, lansoprazole', 'Treatment of', 'over 14 days'], 'conditions': ['Frequent Heartburn']}, 'descriptionModule': {'briefSummary': 'Heartburn, a burning sensation in the chest or throat, occurs in many individuals when acidic stomach contents move upward into the esophagus from the stomach. This study will investigate the safety and efficacy of lansoprazole 15 mg or 30 mg administered once a day in preventing frequent nighttime heartburn.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Experiencing heartburn at least 2 days per week during the nighttime period over the past month.\n* Having heartburn that responds to heartburn medication.\n* Be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion in the study.\n\nExclusion Criteria:\n\n* Having history of erosive esophagitis or gastroesophageal reflux disease diagnosed by a physician and confirmed by testing (endoscopy).\n* Be unwilling to take only the study medication, and antacid provided as a rescue medication for relief of acute heartburn during the study.\n\n"Other protocol-defined inclusion/exclusion criteria may apply"'}, 'identificationModule': {'nctId': 'NCT00701259', 'briefTitle': 'Efficacy/Safety of Lansoprazole in Patients With Frequent Nighttime Heartburn', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase III, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial of Fourteen Day Treatment With Lansoprazole 15 mg or 30 mg Once a Day in Frequent Nighttime Heartburn', 'orgStudyIdInfo': {'id': 'PRSW-GN-305'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '15 mg lansoprazole', 'interventionNames': ['Drug: Lansoprazole']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': '30 mg lansoprazole', 'interventionNames': ['Drug: Lansoprazole']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Lansoprazole', 'type': 'DRUG', 'otherNames': ['Prevacid - United States'], 'description': 'Lansoprazole 15 mg once per day for 14 days', 'armGroupLabels': ['1']}, {'name': 'Lansoprazole', 'type': 'DRUG', 'description': 'Lansoprazole 30 mg once per day for 14 days', 'armGroupLabels': ['2']}, {'name': 'placebo', 'type': 'DRUG', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07054', 'city': 'Parsippany', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Not applicable - enrollment complete', 'geoPoint': {'lat': 40.85788, 'lon': -74.42599}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Regulatory Affairs', 'oldOrganization': 'Novartis'}}}}