Ignite Creation Date:
2025-12-24 @ 2:48 PM
Ignite Modification Date:
2026-02-23 @ 8:09 PM
Study NCT ID:
NCT02409459
Status:
COMPLETED
Last Update Posted:
2018-02-20
First Post:
2015-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Blinded Randomized Placebo-Controlled Study Efficacy and Safety of Injectafer in ID Patients With Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'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': 'C522335', 'term': 'ferric carboxymaltose'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mfalone@luitpold.com', 'phone': '610.650.4200', 'title': 'Mark A. Falone, MD', 'phoneExt': '844', 'organization': 'Luitpold Pharmaceuticals, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '7 months', 'eventGroups': [{'id': 'EG000', 'title': 'Injectafer', 'description': '15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute\n\nInjectafer', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 16, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': '15 cc of Normal Saline IV push at 2 ml/minute\n\nPlacebo: Normal saline solution', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 2, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Patients With a ≥13 Point Improvement in FIQR Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injectafer', 'description': '15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute\n\nInjectafer'}, {'id': 'OG001', 'title': 'Placebo', 'description': '15 cc of Normal Saline IV push at 2 ml/minute\n\nNormal Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 42', 'description': 'The primary efficacy endpoint was the percentage of subjects who had a ≥13-point improvement in the FIQR from baseline to Day 42.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population consisted of all subjects who received at least one dose of randomized treatment. The Efficacy Evaluable Population consisted of all subjects who received at least 1 dose of randomized treatment with at least 1 completed post treatment FIQR evaluation.'}, {'type': 'SECONDARY', 'title': 'Change in BPI, Pain Interference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injectafer', 'description': '15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute\n\nInjectafer'}, {'id': 'OG001', 'title': 'Placebo', 'description': '15 cc of Normal Saline IV push at 2 ml/minute\n\nNormal Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.1', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline in Brief Pain Inventory Pain Interference Score at Day 42', 'description': 'The short version of the Brief Pain Inventory (BPI) includes front and back body diagrams, 4 pain severity items and 7 pain interference items rated on 0-10 scales (with 0 being the best outcome and 10 being the worst outcome), and a question about percentage of pain relief by analgesics. The Pain Interference Score is calculated by adding the scores for the 7 pain interference questions and then dividing by 7 to give a score out of 10.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients without a particular measure at a required time point were excluded from the analysis of that measure.'}, {'type': 'SECONDARY', 'title': 'Change in FIQR Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injectafer', 'description': '15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute\n\nInjectafer'}, {'id': 'OG001', 'title': 'Placebo', 'description': '15 cc of Normal Saline IV push at 2 ml/minute\n\nNormal Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '-45.0', 'spread': '29.5', 'groupId': 'OG000'}, {'value': '-29.7', 'spread': '27.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline in FIQR score at Day 42', 'description': "The FIQR has 21 individual questions. All questions are based on an 11-point numeric rating scale of 0 to 10, with 10 being 'worst' and all questions are framed in the context of the past 7 days. The summed score for function (range 0 to 90) is divided by 3, the summed score for overall impact (range 0 to 20) is not changed, and the summed score for symptoms (range 0 to 100) is divided by 2. The total FIQR is the sum of the three modified domain scores.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients without a particular measure at a required time point were excluded from the analysis of that measure.'}, {'type': 'SECONDARY', 'title': 'Change in BPI, Pain Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injectafer', 'description': '15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute\n\nInjectafer'}, {'id': 'OG001', 'title': 'Placebo', 'description': '15 cc of Normal Saline IV push at 2 ml/minute\n\nNormal Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.1', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline in Brief Pain Inventory Pain Severity Score at Day 42', 'description': 'The short version of the Brief Pain Inventory (BPI) includes front and back body diagrams, 4 pain severity items and 7 pain interference items rated on 0-10 scales (with 0 being the best outcome and 10 being the worst outcome), and a question about percentage of pain relief by analgesics. The Pain Severity Score is calculated by adding the scores for the 4 pain severity questions and then dividing by 4 to give a severity score out of 10.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients without a particular measure at a required time point were excluded from the analysis of that measure.'}, {'type': 'SECONDARY', 'title': 'Change in Fatigue Visual Numeric Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injectafer', 'description': '15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute\n\nInjectafer'}, {'id': 'OG001', 'title': 'Placebo', 'description': '15 cc of Normal Saline IV push at 2 ml/minute\n\nNormal Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.7', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline in Fatigue Visual Numeric Scale at Day 42', 'description': 'Scores range from 0 to 10, with the higher score indicating more fatigue.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients without a particular measure at a required time point were excluded from the analysis of that measure.'}, {'type': 'SECONDARY', 'title': 'Change in Iron Indices, Serum Ferritin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injectafer', 'description': '15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute\n\nInjectafer'}, {'id': 'OG001', 'title': 'Placebo', 'description': '15 cc of Normal Saline IV push at 2 ml/minute\n\nNormal Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '292.5', 'spread': '145.9', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '13.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline in Iron Indices, Serum ferritin at Day 42', 'unitOfMeasure': 'ug/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients without a particular measure at a required time point were excluded from the analysis of that measure.'}, {'type': 'SECONDARY', 'title': 'Change in Iron Indices - Transferrin Saturation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injectafer', 'description': '15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute\n\nInjectafer'}, {'id': 'OG001', 'title': 'Placebo', 'description': '15 cc of Normal Saline IV push at 2 ml/minute\n\nNormal Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '24.4', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '15.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline in Iron Indices, Transferrin saturation, at Day 42', 'unitOfMeasure': 'percent of transferrin saturation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients without a particular measure at a required time point were excluded from the analysis of that measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Injectafer', 'description': '15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute\n\nInjectafer'}, {'id': 'FG001', 'title': 'Placebo', 'description': '15 cc of Normal Saline IV push at 2 ml/minute\n\nNormal Saline'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Group B: Placebo'}, {'id': 'BG001', 'title': 'Injectafer', 'description': 'Group A: Injectafer'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44', 'spread': '10.85', 'groupId': 'BG000'}, {'value': '41', 'spread': '11.07', 'groupId': 'BG001'}, {'value': '43', 'spread': '10.97', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Caucasian', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'Hispanic', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of iron intolerance', 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Yes', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of drug allergy', 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Yes', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'IRLS score per Arm/Group', 'classes': [{'categories': [{'measurements': [{'value': '16.3', 'spread': '14.9', 'groupId': 'BG000'}, {'value': '13.4', 'spread': '13.16', 'groupId': 'BG001'}, {'value': '14.8', 'spread': '14.04', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "'International Restless Legs Syndrome Study Group Rating Scale' (IRLS) The IRLS is composed of 10 items. It gives a global score for all 10 items that is most commonly used as an overall severity score. 9 of the 10 items investigate two dimensions of the RLS severity. Item 3 is part of the diagnostic criteria and does not belong to any of the two dimensions. It is used for the total score for overall RLS severity.\n\nSymptom severity subscale: 0-24 Impact on daily living subscale: 0-12 Global score: 0-40 For all scores, higher score = higher symptom impact.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-22', 'studyFirstSubmitDate': '2015-04-01', 'resultsFirstSubmitDate': '2017-04-18', 'studyFirstSubmitQcDate': '2015-04-03', 'lastUpdatePostDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-14', 'studyFirstPostDateStruct': {'date': '2015-04-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Patients With a ≥13 Point Improvement in FIQR Score', 'timeFrame': 'Day 42', 'description': 'The primary efficacy endpoint was the percentage of subjects who had a ≥13-point improvement in the FIQR from baseline to Day 42.'}], 'secondaryOutcomes': [{'measure': 'Change in BPI, Pain Interference', 'timeFrame': 'Change from Baseline in Brief Pain Inventory Pain Interference Score at Day 42', 'description': 'The short version of the Brief Pain Inventory (BPI) includes front and back body diagrams, 4 pain severity items and 7 pain interference items rated on 0-10 scales (with 0 being the best outcome and 10 being the worst outcome), and a question about percentage of pain relief by analgesics. The Pain Interference Score is calculated by adding the scores for the 7 pain interference questions and then dividing by 7 to give a score out of 10.'}, {'measure': 'Change in FIQR Score', 'timeFrame': 'Change from Baseline in FIQR score at Day 42', 'description': "The FIQR has 21 individual questions. All questions are based on an 11-point numeric rating scale of 0 to 10, with 10 being 'worst' and all questions are framed in the context of the past 7 days. The summed score for function (range 0 to 90) is divided by 3, the summed score for overall impact (range 0 to 20) is not changed, and the summed score for symptoms (range 0 to 100) is divided by 2. The total FIQR is the sum of the three modified domain scores."}, {'measure': 'Change in BPI, Pain Severity', 'timeFrame': 'Change from Baseline in Brief Pain Inventory Pain Severity Score at Day 42', 'description': 'The short version of the Brief Pain Inventory (BPI) includes front and back body diagrams, 4 pain severity items and 7 pain interference items rated on 0-10 scales (with 0 being the best outcome and 10 being the worst outcome), and a question about percentage of pain relief by analgesics. The Pain Severity Score is calculated by adding the scores for the 4 pain severity questions and then dividing by 4 to give a severity score out of 10.'}, {'measure': 'Change in Fatigue Visual Numeric Scale', 'timeFrame': 'Change from Baseline in Fatigue Visual Numeric Scale at Day 42', 'description': 'Scores range from 0 to 10, with the higher score indicating more fatigue.'}, {'measure': 'Change in Iron Indices, Serum Ferritin', 'timeFrame': 'Change from Baseline in Iron Indices, Serum ferritin at Day 42'}, {'measure': 'Change in Iron Indices - Transferrin Saturation', 'timeFrame': 'Change from baseline in Iron Indices, Transferrin saturation, at Day 42'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Iron Deficiency', 'Fibromyalgia']}, 'referencesModule': {'references': [{'pmid': '29149437', 'type': 'DERIVED', 'citation': 'Boomershine CS, Koch TA, Morris D. A Blinded, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of Ferric Carboxymaltose in Iron-Deficient Patients with Fibromyalgia. Rheumatol Ther. 2018 Jun;5(1):271-281. doi: 10.1007/s40744-017-0088-9. Epub 2017 Nov 17.'}]}, 'descriptionModule': {'briefSummary': 'This study investigates the efficacy and safety of an IV iron Injectafer in the treatment of iron deficient patients with fibromyalgia. Eligible subjects will be randomized in a 1:1 ratio to receive Injectafer or Placebo on days 0 and 5. All treated subjects will be followed for efficacy and safety for 42 days.', 'detailedDescription': "This is a blinded, randomized, placebo-controlled study. All subjects who meet the inclusion requirements and no exclusion criteria will be entered into an up to 14 day screening phase. Eligible subjects will be randomized in a 1:1 ratio to receive Injectafer or Placebo on days 0 and 5. All treated subjects will be followed for efficacy and safety for 42 days. Subjects will visit the clinic on days 0 and 5 for treatment, and then on days 14, 28, and 42. The subject's participation in the study will be for approximately 42 days from day 0."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female subject's ≥ 18 years of age, able to give informed consent to the study.\n* Fibromyalgia diagnosis based on The 2011 modification of the American College of Rheumatology (ACR) 's 2010 preliminary criteria for diagnosing fibromyalgia (2011ModCr)\n* A baseline score ≥ 60 on the FIQR\n* Subject's current medications to treat fibromyalgia, including pain medicines, anti-depressants, sleep medications must be on a stable dose for at least 30 days.\n* Subject's current narcotic medication must be on a stable dose for at least 30 days prior to randomization\n* Subjects at risk for pregnancy must have a negative pregnancy test at baseline and be practicing an acceptable form of birth control: have had a hysterectomy or tubal ligation, or otherwise be incapable of pregnancy, or have practiced any of the following methods of contraception for at least one month prior to study entry: hormonal contraceptives, spermicide and barrier, intrauterine device, partner sterility.\n\nExclusion Criteria:\n\n* Parenteral iron use within 4 weeks prior to screening.\n* History of \\> 10 blood transfusions in the past 2 years.\n* Anticipated need for blood transfusion during the study.\n* Known hypersensitivity reaction to any component of Injectafer® (Ferric Carboxymaltose).\n* Current or acute or chronic infection other than viral upper respiratory tract infection\n* Malignancy (other than basal or squamous cell skin cancer or the subject has been cancer free for ≥ 5 years).\n* Active inflammatory arthritis (e.g. rheumatoid arthritis, SLE).\n* Pregnant or lactating women.\n* Severe peripheral vascular disease with significant skin changes.\n* Seizure disorder currently being treated with medication.\n* Baseline ferritin ≥ 50 ng/mL.\n* Baseline TSAT ≥ 20%.\n* History of hemochromatosis or hemosiderosis or other iron storage disorders.\n* Known positive hepatitis with evidence of active disease.\n* Hemoglobin greater than the upper limit of normal.\n* Calcium or phosphorous outside the normal range.\n* Known positive hepatitis B antigen (HBsAg) or hepatitis C viral antibody (HCV) with evidence of active hepatitis (i.e., AST/ALT greater than the upper limit of normal).\n* Known positive HIV-1/HIV-2 antibodies (anti-HIV)\n* Received an investigational drug within 30 days before randomization.\n* Chronic alcohol or drug abuse within the past 6 months.\n* Any other pre-existing laboratory abnormality, medical condition or disease which in view of the investigator participation in this study may put the subject at risk.\n* Subject unable to comply with the study requirements."}, 'identificationModule': {'nctId': 'NCT02409459', 'briefTitle': 'Blinded Randomized Placebo-Controlled Study Efficacy and Safety of Injectafer in ID Patients With Fibromyalgia', 'organization': {'class': 'INDUSTRY', 'fullName': 'American Regent, Inc.'}, 'officialTitle': 'A Blinded, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of Injectafer (Ferric Carboxymaltose) in the Treatment of Iron Deficient Patients With Fibromyalgia', 'orgStudyIdInfo': {'id': '1VIT14038'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Injectafer', 'description': '15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute', 'interventionNames': ['Drug: Injectafer']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '15 cc of Normal Saline IV push at 2 ml/minute', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Injectafer', 'type': 'DRUG', 'otherNames': ['Ferric Carboxymaltose (FCM)'], 'armGroupLabels': ['Injectafer']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Saline solution'], 'description': 'Normal saline solution', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37064', 'city': 'Franklin', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Clinical Research Solutions', 'geoPoint': {'lat': 35.92506, 'lon': -86.86889}}], 'overallOfficials': [{'name': 'Mark A Falone, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'American Regent, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American Regent, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}