Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-26 @ 12:26 AM
Study NCT ID:
NCT01153659
Status:
COMPLETED
Last Update Posted:
2013-11-01
First Post:
2010-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effect on 24-hour, Intragastric pH of RAB ER 50-mg Capsules Compared With Esomeprazole (Nexium) 40 mg Capsules and Rabeprazole (Aciphex) 20-mg Tablets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064750', 'term': 'Rabeprazole'}, {'id': 'D064098', 'term': 'Esomeprazole'}], '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'}, {'id': 'D009853', 'term': 'Omeprazole'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-31', 'studyFirstSubmitDate': '2010-06-28', 'studyFirstSubmitQcDate': '2010-06-29', 'lastUpdatePostDateStruct': {'date': '2013-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of time that intragastric pH remains >4', 'timeFrame': '24-hr period post-dose on Day 5'}], 'secondaryOutcomes': [{'measure': 'Percentage of day- and night-time periods with intragastric pH >4', 'timeFrame': 'Days 1 and 5'}, {'measure': 'Number and duration of nocturnal acid breakthrough (NAB) episodes', 'timeFrame': 'Days 1 and 5'}, {'measure': 'Proportion of subjects with nocturnal acid breakthrough (NAB) episodes', 'timeFrame': 'Days 1 and 5'}]}, 'conditionsModule': {'keywords': ['rabeprazole', 'esomeprazole', 'h. pylori-negative', 'nocturnal acid breakthrough', 'intragastric pH, PK/PD', 'effect on gastric pH in healthy, H. pylori-Negative subjects'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This will be a randomized, open-label, single-center, 3-way crossover study in healthy subjects who are confirmed to be Helicobacter pylori (H. pylori)-negative. The study will consist of 3 study periods separated by a washout period of at least 7 days. Subjects will receive study drugs once daily for 5 days. Barring any safety concerns, subjects will be discharged from the study on Day 6 of Period 3 after completion of discharge procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key inclusion:\n\n* Healthy male and female subjects, including women of child-bearing potential, aged 18 to 55 years, inclusive\n* Subjects who are able to tolerate the insertion and placement of a pH probe on 2 occasions per study period (Day -1 and Day 5)\n\nKey Exclusion:\n\n* Subjects who are H. pylori-positive\n* Subjects who have a history of any gastrointestinal disorder or surgery likely to influence drug absorption (e.g., history of gastric resection)\n* Known hypersensitivity to rabeprazole, esomeprazole, or related compounds or any ingredient in the formulations\n* Other standard clinical pharmacology exclusion criteria for healthy volunteers'}, 'identificationModule': {'nctId': 'NCT01153659', 'briefTitle': 'A Study to Evaluate the Effect on 24-hour, Intragastric pH of RAB ER 50-mg Capsules Compared With Esomeprazole (Nexium) 40 mg Capsules and Rabeprazole (Aciphex) 20-mg Tablets', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'A Randomized, Open-Label, Three-Way Crossover Study to Evaluate the Effect on 24-hour, Intragastric pH Following Daily Oral Dose Administration of RAB ER 50-mg Capsules Compared With Esomeprazole (Nexium) 40-mg Capsules and Rabeprazole (Aciphex) 20-mg Tablets to H. Pylori-Negative Healthy Subjects in a 5-day Treatment Regimen', 'orgStudyIdInfo': {'id': 'E3810-A001-038'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: E3810']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Aciphex (rabeprazole)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'interventionNames': ['Drug: Nexium (esomeprazole)']}], 'interventions': [{'name': 'E3810', 'type': 'DRUG', 'description': 'RAB ER 50 mg capsule once per day on Days 1-5', 'armGroupLabels': ['1']}, {'name': 'Aciphex (rabeprazole)', 'type': 'DRUG', 'description': 'Aciphex (rabeprazole) 20 mg tablet once per day on Days 1-5', 'armGroupLabels': ['2']}, {'name': 'Nexium (esomeprazole)', 'type': 'DRUG', 'description': 'Nexium (esomeprazole) 40 mg capsule once per day on Days 1-5', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Foundation for Digestive Research', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Philip Miner', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oklahoma Foundation for Digestive Research, 1000 N. Lincoln, Suite 210, Oklahoma City, OK 73104 USA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}