Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:17 PM
Study NCT ID:
NCT00607256
Status:
TERMINATED
Last Update Posted:
2019-12-13
First Post:
2008-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-term OL Study of [S,S]-RBX in Patients With 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': 'C524178', 'term': 'O-methyl reboxetine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'dispFirstSubmitDate': '2011-06-07', 'completionDateStruct': {'date': '2009-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-11', 'studyFirstSubmitDate': '2008-01-23', 'dispFirstSubmitQcDate': '2019-12-11', 'studyFirstSubmitQcDate': '2008-01-23', 'dispFirstPostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '12-lead ECG', 'timeFrame': '68 weeks'}, {'measure': 'Hematology/Biochemistry', 'timeFrame': '68 weeks'}, {'measure': 'Adverse events', 'timeFrame': '68 weeks'}, {'measure': 'Physical examination', 'timeFrame': '68 weeks'}, {'measure': 'Vital signs', 'timeFrame': '68 weeks'}], 'secondaryOutcomes': [{'measure': 'Patient Global Impression of Change', 'timeFrame': '68 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Fibromyalgia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6061046&StudyName=Long-term%20OL%20study%20of%20%5BS%2CS%5D-RBX%20in%20patients%20with%20fibromyalgia', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the lon-term safety and tolerability of \\[S,S\\]-reboxetine in patients with fibromyalgia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of patients meeting the ACR criteria for fibromyalgia (i.e. widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)\n\nExclusion Criteria:\n\n* Patients with other severe pain (e.g. DPN and PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia'}, 'identificationModule': {'nctId': 'NCT00607256', 'briefTitle': 'Long-term OL Study of [S,S]-RBX in Patients With Fibromyalgia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Multi-center, Long-term, Open-label Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily in Patients With Fibromyalgia', 'orgStudyIdInfo': {'id': 'A6061046'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open Label', 'interventionNames': ['Drug: [S,S]-reboxetine']}], 'interventions': [{'name': '[S,S]-reboxetine', 'type': 'DRUG', 'description': 'S\\_S reboxetine dosed daily.', 'armGroupLabels': ['Open Label']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95662', 'city': 'Orangevale', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.67851, 'lon': -121.22578}}, {'zip': '92705', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '80239', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '34471', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '34474', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '61265', 'city': 'Moline', 'state': 'Illinois', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.5067, 'lon': -90.51513}}, {'zip': '66206', 'city': 'Prairie Village', 'state': 'Kansas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.99167, 'lon': -94.63357}}, {'zip': '40509', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '65109', 'city': 'Jefferson City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.5767, 'lon': -92.17352}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07033', 'city': 'Kenilworth', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.67649, 'lon': -74.2907}}, {'zip': '14618', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '10312', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'zip': '27511', 'city': 'Cary', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.79154, 'lon': -78.78112}}, {'zip': '58701', 'city': 'Minot', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.23251, 'lon': -101.29627}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43302', 'city': 'Marion', 'state': 'Ohio', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.58867, 'lon': -83.12852}}, {'zip': '97504', 'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'zip': '18015', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'zip': '02920', 'city': 'Cranston', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.77982, 'lon': -71.43728}}, {'zip': '02864', 'city': 'Cumberland', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.96677, 'lon': -71.43284}}, {'zip': '02865', 'city': 'Lincoln', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.92111, 'lon': -71.435}}, {'zip': '02886', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '29621', 'city': 'Anderson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.50344, 'lon': -82.65013}}, {'zip': '29412', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29651', 'city': 'Greer', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.93873, 'lon': -82.22706}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77063', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77566', 'city': 'Lake Jackson', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 29.03386, 'lon': -95.43439}}, {'zip': '78213', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23294', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '23455', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}, {'zip': '99216', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '53209', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '3212', 'city': 'Pellenberg', 'country': 'Belgium', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.87245, 'lon': 4.79394}}, {'zip': 'V1Y 2H4', 'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}, {'zip': 'E1G 1A7', 'city': 'Moncton', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 46.09454, 'lon': -64.7965}}, {'zip': 'H9R 3J1', 'city': 'Pointe-Claire', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 45.44868, 'lon': -73.81669}}, {'zip': 'J1H 1Z1', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': '748 01', 'city': 'Hlučín', 'country': 'Czechia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.89795, 'lon': 18.19196}}, {'zip': '530 02', 'city': 'Pardubice', 'country': 'Czechia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.04075, 'lon': 15.77659}}, {'zip': '128 50', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '760 01', 'city': 'Zlín', 'country': 'Czechia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.22645, 'lon': 17.67065}}, {'zip': '59037', 'city': 'Lille', 'state': 'Cedex', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '06002', 'city': 'Nice', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75181', 'city': 'Paris', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14109', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '85072', 'city': 'Eichstätt', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.88854, 'lon': 11.19675}}, {'zip': '73033', 'city': 'Göppingen', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.70354, 'lon': 9.65209}}, {'zip': '20095', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '68161', 'city': 'Mannheim', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '80336', 'city': 'München', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '65189', 'city': 'Wiesbaden', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}, {'zip': '4819 EV', 'city': 'Breda', 'country': 'Netherlands', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'zip': '7824 AA', 'city': 'Emmen', 'country': 'Netherlands', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 52.77917, 'lon': 6.90694}}, {'zip': '8934 AD', 'city': 'Leeuwarden', 'country': 'Netherlands', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 53.20271, 'lon': 5.80973}}, {'zip': '1462', 'city': 'Boksburg', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -26.21197, 'lon': 28.25958}}, {'zip': '0001', 'city': 'Pretoria', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '7500', 'city': 'Panorama', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Pfizer Investigational Site'}, {'zip': '7500', 'city': 'Parow', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -33.89723, 'lon': 18.59992}}, {'zip': '442-712', 'city': 'Suwon', 'state': 'Kyeongki-do', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'zip': '501-757', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '412 55', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '431 37', 'city': 'Mölndal', 'country': 'Sweden', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 57.6554, 'lon': 12.01378}}, {'zip': '115 22', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '182 88', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': 'CB2 0QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'C04 5JL', 'city': 'Colchester', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.88921, 'lon': 0.90421}}, {'zip': 'DE1 2QY', 'city': 'Derby', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 52.92277, 'lon': -1.47663}}, {'zip': 'DY1 2HQ', 'city': 'Dudley, West Midlands', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 52.5, 'lon': -2.08333}}, {'zip': 'PA16 0XN', 'city': 'Greenock', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 55.94838, 'lon': -4.76121}}, {'zip': 'PA2 7DE', 'city': 'Paisley', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 55.83173, 'lon': -4.43254}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}