Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT00251732
Status:
COMPLETED
Last Update Posted:
2010-08-19
First Post:
2005-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of Pain Modulation in GERD Patients Who Failed Standard Dose Proton Pump Inhibitors (PPI)
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': 'D000928', 'term': 'Antidepressive Agents'}, {'id': 'D064750', 'term': 'Rabeprazole'}], 'ancestors': [{'id': 'D011619', 'term': 'Psychotropic Drugs'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-18', 'studyFirstSubmitDate': '2005-11-08', 'studyFirstSubmitQcDate': '2005-11-08', 'lastUpdatePostDateStruct': {'date': '2010-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom control after 6 weeks of treatment', 'timeFrame': '6 weeks', 'description': 'To measure the outcome after 6 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'Number of drop-outs due to poor symptom control', 'timeFrame': '6 weeks', 'description': 'To measure the number of drop-outs due to poor symptom control.'}, {'measure': 'Level of antacid consumption', 'timeFrame': '6 weeks', 'description': 'To measure the level of antacid consumption due to poor symptom control.'}, {'measure': 'Improvement in quality of life', 'timeFrame': '6 weeks', 'description': 'To improve quality of life with GERD symptom control.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['acid reflux studies', 'efficacy of PPI therapy', 'failing PPI therapy', 'GERD', 'Acid Reflux Disease'], 'conditions': ['Gastroesophageal Reflux Disease']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to evaluate the role of pain modulation in GERD patients who fail to obtain clinical relief with standard dose (once daily) PPI. The study will compare the efficacy of 1) standard dose PPI plus low-dose tricyclic antidepressant (TCA) to, 2) double dose PPI to, 3) standard dose PPI and placebo to determine the relative symptom resolution and health related quality of life in GERD patients who fail standard dose PPI and are randomly assigned to one of these three groups.', 'detailedDescription': 'To evaluate the role of pain modulation in gastroesophageal reflux disease(GERD)patients who fail to obtain clinical relief with standard dose (once daily) proton pump inhibitor(PPI). The study will compare the efficacy; of 1)standard dose PPI plus low-dose tricyclic antidepressant (TCA) to, 2) double dose PPI to, 3) standard dose PPI and placebo to determine the relative symptom resolution and health related quality of life in GERD patients who fail standard dose PPI and are randomly assigned to one of these three groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female\n* Ages 18 to 75\n* At least two episodes of heartburn per week while on PPI once daily\n* Able to communicate with the investigator and comply with the requirements of the study\n* Subjects who give written informed consent after being given a full description of the study.\n\nExclusion Criteria:\n\n* Known allergy or intolerance to TCA\n* Use of antidepressant or a diagnosis of depression\n* History of serious arrhythmia or use of anti-arrhythmics\n* History of seizures\n* Subjects with significant co-morbidity, e.g., cardiovascular, respiratory, urogenital, renal, gastrointestinal, hepatic, hematologic, endocrine, neurologic or psychiatric.\n* Evidence or history of drug abuse within the past 6 months\n* Erosive esophagitis, esophageal ulceration, peptic stricture, Barret's esophagus, or adenocarcinoma of the esophagus on endoscopy.\n* History of esophagogastric surgery\n* Gastric or duodenal lesions (ulcer, tumor, etc)\n* Women who are pregnant or of childbearing age who are not on contraception\n* Patients who are unwilling or unable to provide informed consent"}, 'identificationModule': {'nctId': 'NCT00251732', 'briefTitle': 'Role of Pain Modulation in GERD Patients Who Failed Standard Dose Proton Pump Inhibitors (PPI)', 'organization': {'class': 'FED', 'fullName': 'Southern Arizona VA Health Care System'}, 'officialTitle': 'Role of Pain Modulation in GERD Patients Who Failed Standard Dose PPI.', 'orgStudyIdInfo': {'id': 'Merit Review Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard dose (PPI) plus low dose TCA', 'description': 'Standard dose Rabeprazole(PPI) plus low dose tricyclic antidepressant(TCA)', 'interventionNames': ['Drug: Standard dose (once daily) PPI plus low-dose antidepressant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Double dose PPI', 'description': 'Double dose proton pump inhibitor plus placebo', 'interventionNames': ['Drug: Double dose PPI plus evening placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard dose PPI plus placebo x 2', 'description': 'Standard dose 20 mg. once daily plus Placebo before dinner and placebo before bedtime', 'interventionNames': ['Drug: Rabeprazole , placebo, placebo']}], 'interventions': [{'name': 'Standard dose (once daily) PPI plus low-dose antidepressant', 'type': 'DRUG', 'otherNames': ['Aciphex-PPI', 'Nortriptyline-TCA'], 'description': '20 mg. rabeprazole plus low dose tricyclic antidepressant(TCA)', 'armGroupLabels': ['Standard dose (PPI) plus low dose TCA']}, {'name': 'Double dose PPI plus evening placebo', 'type': 'DRUG', 'otherNames': ['Aciphex-PPI, rabeprazole'], 'description': '20 mg. twice daily with a placebo', 'armGroupLabels': ['Double dose PPI']}, {'name': 'Rabeprazole , placebo, placebo', 'type': 'DRUG', 'otherNames': ['Aciphex-rabeprazole (PPI)', 'Nortriptyline-low-dose tricyclic antidepressant (TCA)'], 'description': '20 mg rabeprazole(PPI) once daily -a.m. placebo -p.m. placebo -bedtime', 'armGroupLabels': ['Standard dose PPI plus placebo x 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85723', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Southern Arizona VA Health Care System', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}], 'overallOfficials': [{'name': 'Ronnie Fass, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SAVAHCS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'collaborators': [{'name': 'Southern Arizona VA Health Care System', 'class': 'FED'}, {'name': 'Janssen Pharmaceutica N.V., Belgium', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Ronnie Fass MD', 'oldOrganization': 'SArizonaVAHCS'}}}}