Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2026-02-20 @ 2:49 PM
Study NCT ID:
NCT01619566
Status:
WITHDRAWN
Last Update Posted:
2019-08-09
First Post:
2012-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cymbalta for Fibromyalgia Pain - Predictive Value of Small Fiber Changed
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068736', 'term': 'Duloxetine Hydrochloride'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Sponsor related', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-07', 'studyFirstSubmitDate': '2012-06-12', 'studyFirstSubmitQcDate': '2012-06-12', 'lastUpdatePostDateStruct': {'date': '2019-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Reduction', 'timeFrame': '12 weeks', 'description': 'Changes in Pain measured by Numeric Pain Rating Scale over time. The Numeric Pain Rating Scale (NPRS) is assessing the patients pain on a 11-point rating scale from 0 - 10 with 0 being no pain at all and 10 being the worst imaginable pain. The test is self-reported and can also be administered by an interviewer.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fibromyalgia', 'Duloxetine', 'Cymbalta', 'Pain', 'Peripheral Nerve', 'Biopsy', 'Predictive'], 'conditions': ['Fibromyalgia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.cymbalta.com/Pages/index.aspx', 'label': 'Drug manufacturers website for study drug'}, {'url': 'http://health.ucsd.edu', 'label': 'Website for location of study'}]}, 'descriptionModule': {'briefSummary': 'Subjects with Fibromyalgia who respond to Duloxetine have specific nerve fiber characteristics. This can be used to predict which future patients will respond to Duloxetine.', 'detailedDescription': 'Subjects will have skin biopsies taken and evaluated for specific pathologies. All subjects will undergo a treatment period with Duloxetine. The analysis will correlate treatment effectiveness with pathological skin biopsy findings to predict future treatment success.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: Treatment Arm\n\n* Fibromyalgia Diagnosis\n* Female\n* Over the age of 18, under the age of 70\n* Understands English\n* Not Pregnant/planning to become pregnant\n\nExclusion Criteria:\n\n* No major psychiatric disorders\n* No major unconrolled systemic diseases which may require hospitalization in the next 6 months\n* Pregnant\n\nInclusion Criteria: Control Arm\n\n* Female\n* Over the age of 18, under the age of 70\n* Understands English\n* Not Pregnant/planning to become pregnant\n\nExclusion Criteria: Control Arm\n\n* No major psychiatric disorders\n* No major unconrolled systemic diseases which may require hospitalization in the next 6 months\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT01619566', 'briefTitle': 'Cymbalta for Fibromyalgia Pain - Predictive Value of Small Fiber Changed', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Duloxetine (Cymbalta): for Fibromyalgia: An Open Label Study to Assess Potential Mechanisms for Fibromyalgia in Peripheral Tissue Innervation That Could Predict Therpeutic Responsiveness to Duloxetine.', 'orgStudyIdInfo': {'id': '111654'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control subjects undergo a skin biopsy.'}, {'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Subjects in the treatment arm also undergo a skin biopsy, followed by 8 week treatment with Duloxetine.', 'interventionNames': ['Drug: Duloxetine']}], 'interventions': [{'name': 'Duloxetine', 'type': 'DRUG', 'otherNames': ['Cymbalta'], 'description': 'oral tablet, 30mg daily for 1 week (titration up) oral tablet, 60mg daily for 8 weeks (treatment) oral tablet, 30mg daily for 1 week (titration down, if needed)', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego Medical Centers', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'tobias moeller-bertram, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'employee'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Clinical Professor of Anesthesia', 'investigatorFullName': 'Tobias Moeller-Bertram', 'investigatorAffiliation': 'University of California, San Diego'}}}}