Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-02 @ 12:36 AM
Study NCT ID:
NCT01089959
Status:
UNKNOWN
Last Update Posted:
2010-08-19
First Post:
2010-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Esomeprazole 40 mg.Daily for 7 Days on Acid Reflux and Related Arousals During Sleep in Patients With 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064098', 'term': 'Esomeprazole'}], '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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-08-18', 'studyFirstSubmitDate': '2010-03-18', 'studyFirstSubmitQcDate': '2010-03-18', 'lastUpdatePostDateStruct': {'date': '2010-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Effect of Esomeprazole 40 mg. Daily for 7 Days on Acid Reflux and Related Arousals During Sleep in Patients w/ GERD.', 'timeFrame': '2 years', 'description': 'This is the first study to evaluate the impact of antireflux treatment, not only on heartburn during sleep, but also on reflux-related conscious awakenings.\n\nThis has not been done previously and will thus provide an opportunity to assess the impact of esomeprazole on nighttime symptoms and awakenings.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acid re-flux,GERD', 'sleep related arousals due to GERD', 'Treatment of acid reflux during sleep in patients with GERD.'], 'conditions': ['Gastroesophageal Reflux Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if esomeprazole 40 mg. once daily improves not only nighttime symptoms but also significantly reduces conscious awakenings associated with gastroesophageal reflux and consequently improves sleep quality.', 'detailedDescription': 'Twenty GERD patients with nighttime heartburn and/or regurgitation at least 3 times a week will be invited to participate in the study. All patients will undergo upper endoscopy to determine presence or absence of esophageal inflammation(using Los Angeles criteria). All patients will be evaluated by the Demographic,Berlin,Epworth Sleepiness Scale Questionnaires, and GERD Symptom Checklist. Thereafter,patients will undergo pH testing w/ an actigraph.The morning of pH probe removal,a Sleep Quality Questionaire will be administered.\n\nSubjects will then receive esomeprazole 40 mg. once daily(30 minutes before breakfast) for 1 week. On day 7,subjects will again undergo pH testing w/ actigraphy, and the results will be analyzed again w/ new integrative software. On the morning of pH probe removal, the sleep Quality Questionnaire will be re-administered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Nocturnal symptoms at least twice a week.\n* Ages 18-80\n* Erosive esophagitis and/or abnormal pH test -\n* Able to read, understand, and complete study questionnaires\n\nExclusion Criteria:\n\n* Subjects with Barrett's esophagus or peptic stricture on endoscopy\n* Subjects with normal endoscopy and pH test\n* Subjects with previous upper gastrointestinal surgery"}, 'identificationModule': {'nctId': 'NCT01089959', 'acronym': 'ISS', 'briefTitle': 'Effect of Esomeprazole 40 mg.Daily for 7 Days on Acid Reflux and Related Arousals During Sleep in Patients With GERD', 'organization': {'class': 'FED', 'fullName': 'Southern Arizona VA Health Care System'}, 'officialTitle': 'The Effect of Esomeprazole 40 mg. Daily for 7 Days on Acid Reflux and Related Arousals During Sleep in Patients With Gastroesophageal Reflux Disease (GERD).', 'orgStudyIdInfo': {'id': 'ISS Astra Zeneca 7 day Nexium'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Esomeprazole', 'description': 'Effect of PPI esomeprazole on acid reflux \\& related arousals during sleep in patients with GERD.', 'interventionNames': ['Drug: Esomeprazole']}], 'interventions': [{'name': 'Esomeprazole', 'type': 'DRUG', 'otherNames': ['Nexium'], 'description': '40 mg daily for 7 days', 'armGroupLabels': ['Esomeprazole']}, {'name': 'esomeprazole', 'type': 'DRUG', 'otherNames': ['Nexium'], 'description': '40 mg. daily, oral medication, once daily for 7 days.', 'armGroupLabels': ['Esomeprazole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85723', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ronnie Fass, MD', 'role': 'CONTACT', 'email': 'ronniefass@va.gov', 'phone': '520-792-1450', 'phoneExt': '5139'}, {'name': 'RONNIE FASS, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Southern Arizona VA Health Care System', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}], 'centralContacts': [{'name': 'RONNIE FASS, MD', 'role': 'CONTACT', 'email': 'ronniefass@va.gov', 'phone': '520-792-1450', 'phoneExt': '5139'}, {'name': 'MARCIA R WILLIS, CCRC', 'role': 'CONTACT', 'email': 'marcia.willis@va.gov', 'phone': '520-792-1450', 'phoneExt': '2032'}], 'overallOfficials': [{'name': 'Ronnie Fass, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SAVAHCS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southern Arizona VA Health Care System', 'class': 'FED'}, 'responsibleParty': {'oldNameTitle': 'RONNIE FASS M.D.', 'oldOrganization': 'SOUTHERN AZ. VA HEALTH CARE SYSTEM'}}}}