Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-06 @ 1:33 AM
Study NCT ID:
NCT00580294
Status:
COMPLETED
Last Update Posted:
2016-02-03
First Post:
2007-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Pilot Study of Switching From One Pain Medication to Another (Opioid Rotation)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D012585', 'term': 'Sciatica'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D020918', 'term': 'Complex Regional Pain Syndromes'}, {'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D006261', 'term': 'Headache'}, {'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D003286', 'term': 'Contracture'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D006562', 'term': 'Herpes Zoster'}, {'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D012600', 'term': 'Scoliosis'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020426', 'term': 'Sciatic Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010111', 'term': 'Oxymorphone'}], 'ancestors': [{'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dionne.bobb@mountsinai.org', 'phone': '212-241-7749', 'title': 'Marco Pappagallo, MD', 'organization': 'Icahn School of Medicine at Mount Sinai'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'This was a pilot open-label study in a small number of participants. A larger randomized study with long-term follow-up and comparison to traditional protocols is necessary to affirm safety. (12 pts had 6 different chronic non-cancer pain diagnoses.)'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Oxymorphone', 'description': 'oral oxymorphone ER as the basal opioid during the first 24 hours and supplemental IV-PCA oxymorphone as needed during period 1. During period 2, participants underwent a 2-week oral titration. The oxymorphone ER and IR dosages were adjusted up or down as needed to maintain pain control.', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Patient Global Impression of Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxymorphone', 'description': 'oral oxymorphone ER as the basal opioid during the first 24 hours and supplemental IV-PCA oxymorphone as needed during period 1. During period 2, participants underwent a 2-week oral titration. The oxymorphone ER and IR dosages were adjusted up or down as needed to maintain pain control.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.19', 'groupId': 'OG000', 'lowerLimit': '0.08', 'upperLimit': '0.44'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 12 hours', 'description': 'PGIC score - participants answered 2 questions regarding change in overall status and overall activity from baseline using a 7-point scale (1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse)', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Brief Pain Inventory', 'timeFrame': 'Assessed daily for 10 days prior to IV PCA treatment, and assessed daily for 2 weeks after IV PCA treatment', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oxymorphone', 'description': 'participants switched to oxymorphone extended release (ER) via both oral and intravenous patient-controlled analgesia (IV-PCA) oxymorphone. After 24 hours, participants were discharged with oral oxymorphone ER and oxymorphone immediate release (IR) as needed'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'study conducted at Mount Sinai School of Medicine, Department of Anesthesiology, Clinical Research Center (CRC), New York, NY, and enrolled patients from August 10, 2007 to August 9, 2008'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Oxymorphone', 'description': 'oral oxymorphone ER as the basal opioid during the first 24 hours and supplemental IV-PCA oxymorphone as needed during period 1. During period 2, participants underwent a 2-week oral titration. The oxymorphone ER and IR dosages were adjusted up or down as needed to maintain pain control.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.4', 'spread': '12.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Average Pain Intensity', 'classes': [{'categories': [{'measurements': [{'value': '7.34', 'spread': '1.18', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Brief Pain Inventory average daily pain (0= no pain, 10=worst imaginable pain)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-04', 'studyFirstSubmitDate': '2007-12-19', 'resultsFirstSubmitDate': '2015-11-25', 'studyFirstSubmitQcDate': '2007-12-19', 'lastUpdatePostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-01-04', 'studyFirstPostDateStruct': {'date': '2007-12-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Patient Global Impression of Change', 'timeFrame': 'baseline and 12 hours', 'description': 'PGIC score - participants answered 2 questions regarding change in overall status and overall activity from baseline using a 7-point scale (1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse)'}, {'measure': 'Brief Pain Inventory', 'timeFrame': 'Assessed daily for 10 days prior to IV PCA treatment, and assessed daily for 2 weeks after IV PCA treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sciatica', 'Diabetic Neuropathies', 'Complex Regional Pain Syndromes', 'Low Back Pain', 'Neck Pain', 'Headache', 'Back Pain', 'Arthritis', 'Brachial Plexus Injury (stinger/burner)', 'Chronic Pain', 'Contractures', 'Diabetes', 'Fibromyalgia', 'Foot Pain', 'Fracture', 'Hip', 'Herpes Zoster (shingles)', 'Migraine', 'Neuropathic Pain', 'Osteoarthritis', 'Osteoporosis', 'Rheumatoid Arthritis', 'Scoliosis', 'Nerve pain', 'Opana', 'Opioid', 'Opioid Rotation', 'Oxymorphone', 'Morphine', 'neuropathic', 'oxycodone'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '21267044', 'type': 'RESULT', 'citation': 'Korkmazsky M, Ghandehari J, Sanchez A, Lin HM, Pappagallo M. Feasibility study of rapid opioid rotation and titration. Pain Physician. 2011 Jan-Feb;14(1):71-82.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if changing from one pain medication like morphine or oxycodone to another pain medication, oxymorphone (OPANA®), will be helpful to patients. This study will examine if the switching from one pain medication to another can be done over a 24 hour period. Oxymorphone, the drug being studied, is an FDA approved drug for treatment of severe pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of 18 to no upper limit\n* Chronic pain of nociceptive, neuropathic, or mixed origin\n* Patients with chronic non cancer pain\n* Ongoing chronic opioid treatment with either oral morphine or oxycodone (long term - more than 3 months of at least a total daily opioid dose of 60 mg morphine or of 30 mg oxycodone)\n* Pain of moderate intensity (\\>4, on the numerical scale 0-10) despite ongoing opioid therapy\\>\n* Non-pregnant, non-lactating women\n* Sufficient language skills to communicate with research staff\n\nExclusion Criteria:Non-ambulatory patients\n\n* Clinically significant respiratory, renal, hepatic, or cardiac disease.\n* Documented diagnosis of sleep apnea (the study physician may exclude patients who present with clinical features and complaints suggestive of a diagnosis of probable sleep apnea)\n* History of illicit drug or alcohol dependence or abuse, abnormal drug taking / seeking behaviors\n* Severe depression (\\> 26 on the BDI)\n* Patients who exhibit a score on the Mini Mental Status Exam (MMSE) of 26 or less. (The range of scores for mild dementia is 21-26 on the MMSE).\n* Workman compensation, current or pending medical-legal litigation\n* Hypersensitivity to study medication (oxymorphone)'}, 'identificationModule': {'nctId': 'NCT00580294', 'briefTitle': 'A Pilot Study of Switching From One Pain Medication to Another (Opioid Rotation)', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'A Pilot Study of Rapid Opioid Rotation and Titration of Oxymorphone', 'orgStudyIdInfo': {'id': 'GCO 07-0464'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'oxymorphone', 'description': 'participants switched to oxymorphone extended release (ER) via both oral and intravenous patient-controlled analgesia (IV-PCA) oxymorphone. After 24 hours, participants were discharged with oral oxymorphone ER and oxymorphone immediate release (IR) as needed', 'interventionNames': ['Drug: Oxymorphone']}], 'interventions': [{'name': 'Oxymorphone', 'type': 'DRUG', 'otherNames': ['Oxymorphone PO', 'Oxymorphone IV'], 'description': 'IV PO', 'armGroupLabels': ['oxymorphone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medcine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Marco Pappagallo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medcine at Mount Sinai'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'collaborators': [{'name': 'Endo Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}