Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-02-20 @ 10:44 PM
Study NCT ID:
NCT02578459
Status:
WITHDRAWN
Last Update Posted:
2019-02-15
First Post:
2015-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study to Evaluate the Efficacy of ITDD vs. CMM in the Treatment of Pancreatic Cancer Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D000072716', 'term': 'Cancer Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The study was never initiated by sponsor. Patients where never recruited.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-13', 'studyFirstSubmitDate': '2015-10-14', 'studyFirstSubmitQcDate': '2015-10-15', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale Pain Scores', 'timeFrame': 'Three months', 'description': 'Level of pain is rated on the visual analog scale. Pain scores after three months of therapy will be compared to baseline pain scores to see if there is a difference.'}], 'secondaryOutcomes': [{'measure': 'Survival Rates', 'timeFrame': 'Two years', 'description': 'Data will be analyzed to test for correlation between survival and pain scores, and survival rates and treatment type.'}, {'measure': 'Quality of Life Scores', 'timeFrame': 'Two years', 'description': 'Difference in quality of life between treatment groups.'}, {'measure': 'Cancer Treatments', 'timeFrame': 'Two years', 'description': 'Difference between treatment group in the number of cancer treatment initiated during the study'}, {'measure': 'Hospitalizations and Emergency Room Visits', 'timeFrame': 'Two years', 'description': 'Difference between treatment group in the number of times they are hospitalized or visit the emergency room during the study'}, {'measure': 'Adverse Events', 'timeFrame': 'Two years', 'description': 'Adverse events reported by each treatment group will be summarized.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cancer pain', 'Intrathecal therapy', 'Pain', 'Pancreatic cancer'], 'conditions': ['Pain Management', 'Cancer Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://menorahmedicalcenter.secure.ehc.com/physicians/profile/Daniel-R-Kloster-MD', 'label': 'Dr. Daniel R. Kloster'}, {'url': 'https://researchmedicalcenter.secure.ehc.com/physicians/profile/Jaswinder-Singh-MD', 'label': 'Dr. Jaswinder Singh'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare efficacy of pain treatment with ITDD to efficacy of pain treatment with CMM in patients with pancreatic cancer pain.', 'detailedDescription': 'This study is a non-randomized, open-label, single-center study that will compare efficacy of pain treatment with ITDD to efficacy of pain treatment with CMM in patients suffering from pancreatic cancer pain.\n\nThere will be two treatment groups: Study group (ITDD): These subjects will have a Prometra System implanted and managed with the appropriate drug regimen to treat their pain. Systemic analgesics will not be prescribed for this group. Control group (CMM): These subjects will be treated with CMM to treat their pain.\n\nA maximum of 30 subjects (maximum of 15 in each treatment group) may be enrolled in this study at one study center.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient has Stage IV pancreatic cancer.\n2. Patient agrees not to be treated by other oncologists or anesthesiologists during the study.\n3. Patient agrees not to obtain pain medications from other physicians during the study.\n4. Patient is at least 22 years of age.\n5. Investigator considers the patient to be able and willing to fulfill all study requirements.\n6. Patient is able to understand the study and provide written informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Patient meets any of the contraindications for use of the Prometra Programmable Infusion System (for patients in the ITDD group).\n2. Patient is enrolled in another clinical study.'}, 'identificationModule': {'nctId': 'NCT02578459', 'briefTitle': 'A Pilot Study to Evaluate the Efficacy of ITDD vs. CMM in the Treatment of Pancreatic Cancer Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Flowonix Medical'}, 'officialTitle': 'A Pilot Study to Evaluate the Efficacy of ITDD vs. CMM in the Treatment of Pancreatic Cancer Pain', 'orgStudyIdInfo': {'id': 'PM-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intrathecal Drug Delivery (ITDD)', 'description': 'These subjects will have a Prometra System implanted and managed with the appropriate drug regimen to treat their pain.', 'interventionNames': ['Device: Intrathecal Drug Delivery System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Medical Management (CMM)', 'description': 'These subjects will be treated with conventional medical management to treat their pain.', 'interventionNames': ['Other: Conventional Medical Management']}], 'interventions': [{'name': 'Intrathecal Drug Delivery System', 'type': 'DEVICE', 'otherNames': ['Prometra Programmable Infusion System'], 'description': 'The Prometra Pump is a battery-operated, implantable, programmable infusion pump that dispenses pain medication into the intrathecal space through an implanted infusion catheter.', 'armGroupLabels': ['Intrathecal Drug Delivery (ITDD)']}, {'name': 'Conventional Medical Management', 'type': 'OTHER', 'description': 'Treatment with conventional medical management will include using standard systemic pain medications such as narcotics, nonsteroidal anti-inflammatory drugs (NSAIDs), and neuropathic medications (examples: gabapentin, Lyrica, Cymbalta) that are typically used to treat pancreatic cancer pain.', 'armGroupLabels': ['Conventional Medical Management (CMM)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66209', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Menorah Medical Center', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'Daniel R Kloster, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Menorah Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Flowonix Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}