Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
Study NCT ID:
NCT00313833
Status:
COMPLETED
Last Update Posted:
2006-05-03
First Post:
2006-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness of Buprenorphine Transdermal System in Elderly Subjects With Chronic Pain: Pilot Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-12'}, 'statusVerifiedDate': '2006-04', 'completionDateStruct': {'date': '2001-11'}, 'lastUpdateSubmitDate': '2006-04-29', 'studyFirstSubmitDate': '2006-04-10', 'studyFirstSubmitQcDate': '2006-04-10', 'lastUpdatePostDateStruct': {'date': '2006-05-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pilot study.'}], 'secondaryOutcomes': [{'measure': 'The following outcome variables were assessed:'}, {'measure': 'average pain intensity in the last 24 hours'}, {'measure': 'acceptability of analgesic therapy'}, {'measure': 'number of nighttime awakenings due to pain last night'}, {'measure': 'quality of sleep'}, {'measure': 'bowel status during the last 24 hours'}, {'measure': 'pain management evaluation'}, {'measure': 'symptom evaluation'}, {'measure': 'staff evaluation of functional independence'}, {'measure': 'resident-defined activity impairment scale'}, {'measure': 'treatment satisfaction questionnaire'}, {'measure': 'Health Assessment Questionnaire'}, {'measure': 'Timed "Up & Go" evaluation'}, {'measure': 'trail making test'}, {'measure': 'digit span test'}, {'measure': 'end of study global evaluation of therapeutic response'}, {'measure': 'modified mini-mental state'}, {'measure': 'examination and geriatric depression scale.'}, {'measure': 'The following measures of health resource utilization were assessed:'}, {'measure': 'use of analgesic medications (usual care plus BTDS) by product type'}, {'measure': 'use of analgesic medications (usual care plus BTDS) by medication and dosage form'}, {'measure': 'use of pain-related adjuvant medications by product type'}, {'measure': 'number of phone calls to physicians for pain management'}, {'measure': 'number of physician visits for pain management'}, {'measure': 'and use of medications for the treatment of drug-related adverse events.'}]}, 'conditionsModule': {'keywords': ['Chronic pain', 'elderly', 'supervised living', 'opioid', 'transdermal'], 'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': 'This pilot study was designed to evaluate the effectiveness and tolerability of the buprenorphine transdermal system versus placebo on health outcomes in elderly residents in supervised living environments. The treatment intervention duration is 42 days during which time supplemental analgesic medication (usual analgesic care) will be provided to all subjects in addition to study drug.', 'detailedDescription': 'Buprenorphine is a synthetic opioid analgesic with over twenty-five years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* residing in a nursing home, assisted living environment, or any type of supervised living situation in which the principal investigator maintained primary responsibility for the analgesic management of the resident.\n* chronic pain of musculoskeletal origin who had been managed with short-acting opioids.\n\nExclusion Criteria:\n\n* taking \\>90 mg oral morphine sulfate per day (during any single day) or \\>50 mcg/hr of transdermal fentanyl or its equivalent.\n* activity restricted totally to bed rest.\n* have cancer-related pain.\n\nOther protocol-specific exclusion/inclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00313833', 'briefTitle': 'Safety and Effectiveness of Buprenorphine Transdermal System in Elderly Subjects With Chronic Pain: Pilot Study.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Purdue Pharma LP'}, 'officialTitle': 'A Randomized, Double Blind, Pilot Evaluation of the Effectiveness of BTDS Versus Placebo on Health Outcomes Associated With Analgesic Management of Elderly Residents in Supervised Living Environments', 'orgStudyIdInfo': {'id': 'BUP3002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Buprenorphine transdermal delivery system', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35235', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Birmingham Health Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85023', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Research Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Advanced Clinical Research Institute', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '06488', 'city': 'Southbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Associated Physicians of Southbury', 'geoPoint': {'lat': 41.48148, 'lon': -73.21317}}, {'zip': '33445', 'city': 'Delray Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Life Care Home Health Services', 'geoPoint': {'lat': 26.46146, 'lon': -80.07282}}, {'zip': '66206', 'city': 'Leawood', 'state': 'Kansas', 'country': 'United States', 'facility': 'Ward Parkway Health Services', 'geoPoint': {'lat': 38.96667, 'lon': -94.6169}}, {'zip': '21208', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Atlantic Medical Group LLC', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48089', 'city': 'Warren', 'state': 'Michigan', 'country': 'United States', 'facility': 'Bortz Health Care of Warren', 'geoPoint': {'lat': 42.49044, 'lon': -83.01304}}, {'zip': '65807', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Bio-Test Clinic', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '11542', 'city': 'Glen Cove', 'state': 'New York', 'country': 'United States', 'facility': 'Glengariff Health Care Center', 'geoPoint': {'lat': 40.86232, 'lon': -73.63374}}, {'zip': '10469', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Kings Harbor Multicare Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '43207', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Regency Manor', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Associated Medical Services Inc', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97266', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Town Center Village', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '16601', 'city': 'Altoona', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Center for Pain Management', 'geoPoint': {'lat': 40.51868, 'lon': -78.39474}}, {'zip': '16063', 'city': 'Zelienople', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'LAS/Health and Wellness Center', 'geoPoint': {'lat': 40.79451, 'lon': -80.13673}}, {'zip': '77520', 'city': 'Baytown', 'state': 'Texas', 'country': 'United States', 'facility': 'Geriatric Associates of America Inc PA', 'geoPoint': {'lat': 29.7355, 'lon': -94.97743}}, {'zip': '54946', 'city': 'King', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Wisconsin Veterans Home', 'geoPoint': {'lat': 44.33748, 'lon': -89.14178}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Purdue Pharma LP', 'class': 'INDUSTRY'}}}}