Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 6:12 AM
Study NCT ID:
NCT00002160
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter Phase II/III, Placebo-Controlled Study of SNX-111 Administered Intrathecally to Cancer and AIDS Patients With Chronic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D000386', 'term': 'AIDS-Related Complex'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C078452', 'term': 'ziconotide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1998-03', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Acquired Immunodeficiency Syndrome', 'AIDS-Related Complex', 'Pain', 'Palliative Care', 'omega-conopeptide MVIIA', 'Calcium Channel Blockers'], 'conditions': ['HIV Infections', 'Cancer', 'Pain']}, 'descriptionModule': {'briefSummary': 'To determine the safety and efficacy of SNX-111 in controlling severe, chronic pain in cancer and AIDS patients.', 'detailedDescription': 'Patients are randomized to receive SNX-111 or placebo (AS PER AMENDMENT 1/22/98: with randomization weighted 2:1 in favor of SNX-111) via external pump and an intrathecal catheter (thin tube inserted into the spinal canal). (AS PER AMENDMENT 1/22/98: the dose is increased every 24 hours, in the absence of onset of analgesia or adverse events. After 2-5 days, patients who respond to their medication continue treatment at home for 5-8 days. Patients who do not respond will be switched to the other regimen (i.e., placebo to SNX-111, or SNX-111 to placebo). After 10 days, responding patients are unblinded and asked to enroll in the long-term, open-label extension protocol. Patients remain on a fixed dose at the therapeutic level found in the previous study. The dose may be increased or decreased at the discretion of the investigator. Patients may continue therapy on a long-term basis until the drug is approved.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Rescue analgesia.\n\nPatients must have:\n\n* Chronic pain related to AIDS or cancer.\n* Unsatisfactory response to prior opioid therapy.\n* Life expectancy \\> 3 months (or 1 month if an infusion pump is in place).\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Signs of sepsis or inadequately treated infection.\n\nPatients with the following prior conditions are excluded:\n\nHistory of heart disease, heart failure, or asthma.'}, 'identificationModule': {'nctId': 'NCT00002160', 'briefTitle': 'A Multicenter Phase II/III, Placebo-Controlled Study of SNX-111 Administered Intrathecally to Cancer and AIDS Patients With Chronic Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'A Multicenter Phase II/III, Placebo-Controlled Study of SNX-111 Administered Intrathecally to Cancer and AIDS Patients With Chronic Pain', 'orgStudyIdInfo': {'id': '256A'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ziconotide', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Ctr for Pain Management and Rehabilitation', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '36603', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Gulf Coast Clinical Services', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '35476', 'city': 'Northport', 'state': 'Alabama', 'country': 'United States', 'facility': 'Northport Hosp', 'geoPoint': {'lat': 33.22901, 'lon': -87.57723}}, {'zip': '72901', 'city': 'Fort Smith', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Holt Krock Clinic', 'geoPoint': {'lat': 35.38592, 'lon': -94.39855}}, {'zip': '94704', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Alta Bates Hosp', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '917414240', 'city': 'Glendora', 'state': 'California', 'country': 'United States', 'facility': 'Pain Diagnosis and Treatment', 'geoPoint': {'lat': 34.13612, 'lon': -117.86534}}, {'zip': '921038770', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Univ of CA - San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '95124', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Good Samaritan Hosp Ctr', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '06810', 'city': 'Danbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Connecticut Pain Care', 'geoPoint': {'lat': 41.39482, 'lon': -73.45401}}, {'zip': '20422', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'VA Med Ctr / Oncology Section', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Univ of Miami School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H Lee Moffit Cancer Ctr and Research Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Univ Hosp', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Cook County Hosp', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Pain Control Ctr', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46514', 'city': 'Elkhardt', 'state': 'Indiana', 'country': 'United States', 'facility': 'Elkhardt Gen Hosp'}, {'zip': '47804', 'city': 'Terre Haute', 'state': 'Indiana', 'country': 'United States', 'facility': 'Neurosurgical Associates', 'geoPoint': {'lat': 39.4667, 'lon': -87.41391}}, {'zip': '522421061', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Univ of Iowa Hosp', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '661607415', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Univ of Kansas Med Ctr', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '70062', 'city': 'Kenner', 'state': 'Louisiana', 'country': 'United States', 'facility': 'New Orleans Pharmaceutical Research', 'geoPoint': {'lat': 29.99409, 'lon': -90.24174}}, {'zip': '711303932', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana State Univ', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hosp', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hosp", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55417', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis Veterans Administration', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Univ of Missouri Med Ctr', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '64132', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'The Pain Institute', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '08103', 'city': 'Camden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cooper Hospital Early Intervention Program', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'zip': '08540', 'city': 'Princeton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Clinical Solutions', 'geoPoint': {'lat': 40.34872, 'lon': -74.65905}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Pain Management', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11776', 'city': 'Port Jefferson Station', 'state': 'New York', 'country': 'United States', 'facility': 'Long Island Pain Management', 'geoPoint': {'lat': 40.92538, 'lon': -73.04733}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Univ of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Bowman Gray School of Medicine / Wake Forest Univ', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '18104', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lehigh Valley Hosp', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pennsylvania State College of Medicine', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson Univ Hosp', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '38104', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Methodist Hosp', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '38163', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Univ of Tennessee', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '79430', 'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Tech Univ Health Science Ctr', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}, {'zip': '782847838', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Univ of Texas Health Sciences Ctr', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '220423300', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Fairfax Hosp', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Pain Management', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98133', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Neuroscience Institute', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '544495777', 'city': 'Marshfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Marschfield Clinic', 'geoPoint': {'lat': 44.66885, 'lon': -90.1718}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neurex', 'class': 'INDUSTRY'}}}}