Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2026-01-01 @ 12:16 AM
Study NCT ID:
NCT00125892
Status:
COMPLETED
Last Update Posted:
2007-05-17
First Post:
2005-07-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Duloxetine in the Treatment of Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], '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'}]}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-05-16', 'studyFirstSubmitDate': '2005-07-29', 'studyFirstSubmitQcDate': '2005-07-29', 'lastUpdatePostDateStruct': {'date': '2007-05-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate safety and efficacy of duloxetine in patients diagnosed with fibromyalgia syndrome'}], 'secondaryOutcomes': [{'measure': 'Evaluate persistence of efficacy'}, {'measure': 'Evaluate long-term differences in efficacy in different doses'}, {'measure': 'Evaluate gains in efficacy in non-responders'}]}, 'conditionsModule': {'conditions': ['Fibromyalgia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate duloxetine for the treatment of fibromyalgia syndrome patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet criteria for primary fibromyalgia syndrome as defined by the American College of Rheumatologists\n\nExclusion Criteria:\n\n* Treatment with a monoamine oxidase inhibitor within 14 days prior to Visit 2 or the potential need to take within 5 days after discontinuation from the study.\n* Any patients judged by their physicians to be at serious suicidal risk.\n* Have uncontrolled narrow-angle glaucoma'}, 'identificationModule': {'nctId': 'NCT00125892', 'briefTitle': 'A Study of Duloxetine in the Treatment of Fibromyalgia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A 1-Year Safety Study of Duloxetine in Patients With Fibromyalgia Syndrome', 'orgStudyIdInfo': {'id': '9075'}, 'secondaryIdInfos': [{'id': 'F1J-MC-HMEH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'duloxetine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Capital Federal', 'country': 'Argentina', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician'}, {'zip': '4558', 'city': 'Cotton Tree', 'state': 'Queensland', 'country': 'Australia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician', 'geoPoint': {'lat': -26.65355, 'lon': 153.10116}}, {'zip': '3144', 'city': 'Malvern', 'state': 'Victoria', 'country': 'Australia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician', 'geoPoint': {'lat': -37.86259, 'lon': 145.02811}}, {'city': 'Hobart', 'country': 'Australia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician', 'geoPoint': {'lat': -42.87936, 'lon': 147.32941}}, {'city': 'Melbourne', 'country': 'Australia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '80060-240', 'city': 'Curitiba', 'country': 'Brazil', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'zip': '74043-110', 'city': 'Goiânia', 'country': 'Brazil', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'zip': '52020-010', 'city': 'Recife', 'country': 'Brazil', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}, {'zip': '20551-030', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': 'A1C 2H5', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'N6A 4V2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'M5T 3A9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'S7K 0H6', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}, {'city': 'Morelia', 'state': 'Michoacán', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician', 'geoPoint': {'lat': 19.70078, 'lon': -101.18443}}, {'city': 'Mérida', 'state': 'Yucatán', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician', 'geoPoint': {'lat': 20.967, 'lon': -89.62318}}, {'city': 'Guadalajara', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday -Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'city': 'Mexico City', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday -Friday from 9:00AM to 5:00PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Lublin', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'city': 'Poznan', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial. contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Szczecin', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}, {'city': 'Wroclaw', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'city': 'Taichung', 'country': 'Taiwan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your person physician', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours , EST ) or speak with your personal physician', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}]}}}