Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT00228605
Status:
COMPLETED
Last Update Posted:
2014-05-09
First Post:
2005-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating the Safety and Tolerability of OraVescent Fentanyl for Opioid Tolerant Patients With Noncancer Related Breakthrough Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D020773', 'term': 'Headache Disorders'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-08', 'studyFirstSubmitDate': '2005-09-27', 'studyFirstSubmitQcDate': '2005-09-27', 'lastUpdatePostDateStruct': {'date': '2014-05-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability when used over a 12-month period for the management of breakthrough pain in opioid tolerant patients'}], 'secondaryOutcomes': [{'measure': "Assess the patients' quality of life through questionnaires"}, {'measure': "Assess the patients' overall medication preferences"}, {'measure': "Assess the patients' overall medication performance"}]}, 'conditionsModule': {'keywords': ['Pain', 'Sudden Pain', 'Flares', 'noncancer', 'low back pain', 'neuropathic pain', 'osteoarthritis pain', 'migraine', 'chronic headache', 'diabetic peripheral neuropathy'], 'conditions': ['Low Back Pain', 'Migraine', 'Diabetic Neuropathies', 'Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and tolerability of OraVescent fentanyl for the potential treatment of breakthrough pain episodes in patients who have chronic noncancer pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic pain diagnosis\n* Opioid tolerant\n* Has on average 1-4 breakthrough pain episodes per day\n\nExclusion Criteria:\n\n* Drug abuse history\n* Cardiopulmonary disease\n* Monoamine oxidase inhibitors (MAOIs)\n* Expected to have surgery to relieve the pain'}, 'identificationModule': {'nctId': 'NCT00228605', 'briefTitle': 'Evaluating the Safety and Tolerability of OraVescent Fentanyl for Opioid Tolerant Patients With Noncancer Related Breakthrough Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'An Open-Label 12 Month Study to Evaluate the Safety, Tolerability and Efficacy of OraVescent Fentanyl Citrate for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Chronic Noncancer Pain', 'orgStudyIdInfo': {'id': 'C25608/3040/BP/US'}}, 'armsInterventionsModule': {'interventions': [{'name': 'OraVescent Fentanyl', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35040', 'city': 'Calera', 'state': 'Alabama', 'country': 'United States', 'facility': 'MedSearch', 'geoPoint': {'lat': 33.1029, 'lon': -86.7536}}, {'zip': '35216', 'city': 'Hoover', 'state': 'Alabama', 'country': 'United States', 'facility': 'Clinical Research Consultants, Inc.', 'geoPoint': {'lat': 33.40539, 'lon': -86.81138}}, {'zip': '85023', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Research Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72404', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'NEA Clinic', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '80909', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 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