Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2026-02-02 @ 2:00 AM
Study NCT ID:
NCT02972359
Status:
COMPLETED
Last Update Posted:
2019-11-21
First Post:
2016-11-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety of Intravenous Neridronic Acid in CRPS
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020918', 'term': 'Complex Regional Pain Syndromes'}], 'ancestors': [{'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C053389', 'term': '6-amino-1-hydroxyhexane-1,1-diphosphonate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials@grunenthal.com', 'phone': '+49 241 569', 'title': 'Clinical Trial Helpdesk', 'phoneExt': '3223', 'organization': 'Grünenthal GmbH'}, 'certainAgreement': {'otherDetails': 'The sponsor reserves the right to review any proposed presentation of the results of this trial before they are submitted for publication or public disclosure. Neither party (e.g., the sponsor, the coordinating investigator) has the right to prohibit publication or public disclosure unless it can be shown to affect possible patent rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Due to the open-label, uncontrolled nature of the trial and the concomitant use of pain medication, the effect of neridronic acid on pain intensity and the side effect profile of neridronic acid have to be interpreted with care.'}}, 'adverseEventsModule': {'timeFrame': 'Day 1 to Week 52', 'description': '318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set).\n\nParticipants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented.\n\nTreatment emergent adverse events are reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Neridronic Acid', 'description': 'Neridronic acid 100 mg administered on Day 1, Day 4, Day 7, and Day 10, resulting in a total dose of neridronic acid 400 mg.\n\nNeridronic acid: Neridronic acid administered as intravenous infusion.', 'otherNumAtRisk': 316, 'deathsNumAtRisk': 316, 'otherNumAffected': 275, 'seriousNumAtRisk': 316, 'deathsNumAffected': 1, 'seriousNumAffected': 27}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 96, 'numAffected': 65}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 70, 'numAffected': 52}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 46, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 39, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Condition aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 44, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 37, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 31, 'numAffected': 27}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 30, 'numAffected': 25}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 30, 'numAffected': 25}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 19, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}], 'seriousEvents': [{'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Stress cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Condition aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cystocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Leg amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Occurrence of Any Treatment Emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Neridronic Acid', 'description': 'Neridronic acid 100 mg administered on Day 1, Day 4, Day 7, and Day 10, resulting in a total dose of neridronic acid 400 mg.\n\nNeridronic acid: Neridronic acid administered as intravenous infusion.'}], 'classes': [{'title': 'Participants with TEAE', 'categories': [{'measurements': [{'value': '277', 'groupId': 'OG000'}]}]}, {'title': 'Participants with serious TEAE', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Participants with non-serious TEAE', 'categories': [{'measurements': [{'value': '275', 'groupId': 'OG000'}]}]}, {'title': 'Participants with unexpected TEAE', 'categories': [{'measurements': [{'value': '267', 'groupId': 'OG000'}]}]}, {'title': 'Participants with related TEAE', 'categories': [{'measurements': [{'value': '190', 'groupId': 'OG000'}]}]}, {'title': 'Participants with related serious TEAE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Participants with TEAE leading to IMP discont.', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Participants with TEAE leading to trial discont.', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Week 52', 'description': 'The primary endpoint of this trial was a binary endpoint assessing whether or not a participant experienced any TEAE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Occurrence of Permanent Discontinuation From Treatment Due to an Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Neridronic Acid', 'description': 'Neridronic acid 100 mg administered on Day 1, Day 4, Day 7, and Day 10, resulting in a total dose of neridronic acid 400 mg.\n\nNeridronic acid: Neridronic acid administered as intravenous infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Day 10', 'description': 'The investigator could choose to permanently discontinue a participant from treatment if continued exposure of the participant to neridronic acid could have posed an undue risk to the participant.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Current Pain Intensity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Neridronic Acid', 'description': 'Neridronic acid 100 mg administered on Day 1, Day 4, Day 7, and Day 10, resulting in a total dose of neridronic acid 400 mg.\n\nNeridronic acid: Neridronic acid administered as intravenous infusion.'}], 'classes': [{'title': 'Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.54', 'spread': '2.27', 'groupId': 'OG000'}]}]}, {'title': 'Baseline to Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.57', 'spread': '2.45', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12 and Week 26', 'description': 'The current Complex Regional Pain Syndrome (CRPS)-related pain intensity score was captured at each visit using an 11-point numerical rating scale where 0 = "no pain" and 10 = "pain as bad as you can imagine", a higher score indicates more pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Response to Treatment, Defined as at Least 30% Decrease From Baseline in the Current Pain Intensity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Neridronic Acid', 'description': 'Neridronic acid 100 mg administered on Day 1, Day 4, Day 7, and Day 10, resulting in a total dose of neridronic acid 400 mg.\n\nNeridronic acid: Neridronic acid administered as intravenous infusion.'}], 'classes': [{'title': 'At least 30% pain reduction - Week 12', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}]}]}, {'title': 'At least 30% pain reduction - Week 26', 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, at Week 12 and Week 26', 'description': 'Participants with at least a 30 percent decrease in the current pain intensity score were considered to have responded to treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Response to Treatment, Defined as at Least 50% Decrease From Baseline in the Current Pain Intensity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Neridronic Acid', 'description': 'Neridronic acid 100 mg administered on Day 1, Day 4, Day 7, and Day 10, resulting in a total dose of neridronic acid 400 mg.\n\nNeridronic acid: Neridronic acid administered as intravenous infusion.'}], 'classes': [{'title': 'At least 50% pain reduction - Week 12', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}, {'title': 'At least 50% pain reduction - Week 26', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, at Week 12 and Week 26', 'description': 'Participants with at least a 50 percent decrease in the current pain intensity score were considered to have responded to treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Patient Global Impression of Change (PGIC) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Neridronic Acid', 'description': 'Neridronic acid 100 mg administered on Day 1, Day 4, Day 7, and Day 10, resulting in a total dose of neridronic acid 400 mg.\n\nNeridronic acid: Neridronic acid administered as intravenous infusion.'}], 'classes': [{'categories': [{'title': 'Very Much Improved', 'measurements': [{'value': '31', 'groupId': 'OG000'}]}, {'title': 'Much Improved', 'measurements': [{'value': '71', 'groupId': 'OG000'}]}, {'title': 'Minimally Improved', 'measurements': [{'value': '98', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '45', 'groupId': 'OG000'}]}, {'title': 'Minimally Worse', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'Much Worse', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Very Much Worse', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at Week 12', 'description': 'The Patient Global Impression of Change (PGIC) is a self-reported measure of perceived change in overall condition since the start of the study. Participants selected one of seven responses ranging from "very much improved" to "very much worse". A response of "very much improved" or "much improved" is generally regarded as a clinically important improvement.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set; 286 out of 316 participants attended the visit at Week 12 and were asked to complete the PGIC questionnaire.'}, {'type': 'SECONDARY', 'title': 'Patient Global Impression of Change (PGIC) at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Neridronic Acid', 'description': 'Neridronic acid 100 mg administered on Day 1, Day 4, Day 7, and Day 10, resulting in a total dose of neridronic acid 400 mg.\n\nNeridronic acid: Neridronic acid administered as intravenous infusion.'}], 'classes': [{'categories': [{'title': 'Very Much Improved', 'measurements': [{'value': '38', 'groupId': 'OG000'}]}, {'title': 'Much Improved', 'measurements': [{'value': '58', 'groupId': 'OG000'}]}, {'title': 'Minimally Improved', 'measurements': [{'value': '84', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '52', 'groupId': 'OG000'}]}, {'title': 'Minimally Worse', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': 'Much Worse', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Very Much Worse', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at Week 26', 'description': 'The Patient Global Impression of Change (PGIC) is a self-reported measure of perceived change in overall condition since the start of the study. Participants selected one of seven responses ranging from "very much improved" to "very much worse". A response of "very much improved" or "much improved" is generally regarded as a clinically important improvement.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set; 273 out of 316 participants attended the visit at Week 26 and were asked to complete the PGIC questionnaire.'}, {'type': 'SECONDARY', 'title': 'Change in the Pain Interference Score of the Brief Pain Inventory (BPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Neridronic Acid', 'description': 'Neridronic acid 100 mg administered on Day 1, Day 4, Day 7, and Day 10, resulting in a total dose of neridronic acid 400 mg.\n\nNeridronic acid: Neridronic acid administered as intravenous infusion.'}], 'classes': [{'title': 'Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '2.49', 'groupId': 'OG000'}]}]}, {'title': 'Baseline to Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '2.64', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12 and Week 26', 'description': 'The Brief Pain Inventory (BPI) Interference Score is the mean value of 7 self-reported items in question 9 of the BPI Short Form Questionnaire. Participants rated their interference of pain with general activity, walking, work, sleep and other activities in the past 24 hours, with possible ratings from 0 (does not interfere) to 10 (completely interferes). The BPI interference Score ranges from 0 to 10, with higher values indicating greater pain interference of daily activities.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Neridronic Acid', 'description': 'Neridronic acid 100 mg administered on Day 1, Day 4, Day 7, and Day 10, resulting in a total dose of neridronic acid 400 mg as intravenous infusion.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '318'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '247'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}]}], 'dropWithdraws': [{'type': 'Incl. criteria not met/Exclusion met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'Other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The first participant was enrolled on 20 December 2016.', 'preAssignmentDetails': 'A total of 580 participants signed an informed consent form, 318 participants hereof were allocated to treatment. Two of the allocated participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants received treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Neridronic Acid', 'description': 'Neridronic acid 100 mg administered on Day 1, Day 4, Day 7, and Day 10, resulting in a total dose of neridronic acid 400 mg.\n\nNeridronic acid: Neridronic acid administered as intravenous infusion.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '290', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '47.4', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '77'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '237', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '79', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '300', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '297', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '308', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '28.3', 'spread': '7.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline current pain intensity 11-point NRS', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6.59', 'spread': '1.58', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Measured using an 11-point Numerical rating scale (NRS) by answering the following question: "Please rate your pain by selecting the one number that best describes how much pain you have right now." Scores ranged from 0 (no pain) to 10 (pain as bad as you can imagine), a higher score indicates more pain. Baseline was the score assessed before the first dose of investigational medicinal product (IMP).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': "One participant's baseline pain assessment was missing (N=315). Full Analysis Set"}, {'title': 'Baseline Pain Interference score of the Brief Pain Inventory (BPI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7.3', 'spread': '1.75', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Participants completed the Brief Pain Inventory (BPI) Interference Scale questionnaire, which measures the impact of pain on functioning and well-being. The 7 pain interference items: general activity, walking, work, mood, enjoyment of life, relations with others, and sleep, are each rated on a 0 to 10 scale using a 24-hour recall period, with 0 indicating "does not interfere" and 10 indicating "completely interferes". The total Pain Interference Score is calculated by adding the scores for the 7 questions and dividing by 7. This gives an interference score with a range from 0 to 10.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '20 participants baseline pain assessment were missing. Full Analysis Set'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-17', 'size': 2322807, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-10-11T02:42', 'hasProtocol': True}, {'date': '2018-05-15', 'size': 581520, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-10-11T02:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 580}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-12', 'studyFirstSubmitDate': '2016-11-21', 'resultsFirstSubmitDate': '2019-10-15', 'studyFirstSubmitQcDate': '2016-11-21', 'lastUpdatePostDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-15', 'studyFirstPostDateStruct': {'date': '2016-11-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Occurrence of Any Treatment Emergent Adverse Event (TEAE)', 'timeFrame': 'Day 1 to Week 52', 'description': 'The primary endpoint of this trial was a binary endpoint assessing whether or not a participant experienced any TEAE.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Occurrence of Permanent Discontinuation From Treatment Due to an Adverse Event', 'timeFrame': 'Day 1 to Day 10', 'description': 'The investigator could choose to permanently discontinue a participant from treatment if continued exposure of the participant to neridronic acid could have posed an undue risk to the participant.'}, {'measure': 'Change From Baseline in the Current Pain Intensity Score', 'timeFrame': 'Baseline to Week 12 and Week 26', 'description': 'The current Complex Regional Pain Syndrome (CRPS)-related pain intensity score was captured at each visit using an 11-point numerical rating scale where 0 = "no pain" and 10 = "pain as bad as you can imagine", a higher score indicates more pain.'}, {'measure': 'Number of Participants With Response to Treatment, Defined as at Least 30% Decrease From Baseline in the Current Pain Intensity Score', 'timeFrame': 'Baseline, at Week 12 and Week 26', 'description': 'Participants with at least a 30 percent decrease in the current pain intensity score were considered to have responded to treatment.'}, {'measure': 'Number of Participants With Response to Treatment, Defined as at Least 50% Decrease From Baseline in the Current Pain Intensity Score', 'timeFrame': 'Baseline, at Week 12 and Week 26', 'description': 'Participants with at least a 50 percent decrease in the current pain intensity score were considered to have responded to treatment.'}, {'measure': 'Patient Global Impression of Change (PGIC) at Week 12', 'timeFrame': 'at Week 12', 'description': 'The Patient Global Impression of Change (PGIC) is a self-reported measure of perceived change in overall condition since the start of the study. Participants selected one of seven responses ranging from "very much improved" to "very much worse". A response of "very much improved" or "much improved" is generally regarded as a clinically important improvement.'}, {'measure': 'Patient Global Impression of Change (PGIC) at Week 26', 'timeFrame': 'at Week 26', 'description': 'The Patient Global Impression of Change (PGIC) is a self-reported measure of perceived change in overall condition since the start of the study. Participants selected one of seven responses ranging from "very much improved" to "very much worse". A response of "very much improved" or "much improved" is generally regarded as a clinically important improvement.'}, {'measure': 'Change in the Pain Interference Score of the Brief Pain Inventory (BPI)', 'timeFrame': 'Baseline to Week 12 and Week 26', 'description': 'The Brief Pain Inventory (BPI) Interference Score is the mean value of 7 self-reported items in question 9 of the BPI Short Form Questionnaire. Participants rated their interference of pain with general activity, walking, work, sleep and other activities in the past 24 hours, with possible ratings from 0 (does not interfere) to 10 (completely interferes). The BPI interference Score ranges from 0 to 10, with higher values indicating greater pain interference of daily activities.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neridronic Acid', 'Neridronate', 'CRPS', 'RSD (reflex sympathetic dystrophy)'], 'conditions': ['Complex Regional Pain Syndrome']}, 'referencesModule': {'references': [{'pmid': '19414839', 'type': 'BACKGROUND', 'citation': 'Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J; CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009 May 5;150(9):604-12. doi: 10.7326/0003-4819-150-9-200905050-00006.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this trial was to investigate the safety of intravenous neridronic acid in patients with complex regional pain syndrome (CRPS).\n\nThe trial was divided into 3 periods: a 60-day enrollment period, a treatment period consisting of 4 infusions over 10 days, and a follow-up period of approximately 50 weeks (with visits at Week 2, Week 6, Week 12, Week 26, Week 39, and Week 52).', 'detailedDescription': 'At the Enrollment Visit the trial objectives, procedures, and risks were explained to the participants and the informed consent form was signed. Medical history was obtained, a physical examination was conducted, and other safety assessments were performed. Signs and symptoms of CRPS were assessed to confirm the diagnosis of CRPS according to the Budapest clinical criteria. Participants were trained to report their pain. Calcium and vitamin D supplementation were initiated to ensure sufficient vitamin D levels prior to treatment.\n\nParticipants meeting all eligibility criteria received infusions of investigational medicinal product (IMP) during visits on Day 1, Day 4, Day 7, and Day 10. Flexibility of ±1 day was allowed for Day 4, Day 7, and Day 10 whilst ensuring a minimum period of 48 hours between infusions. During the treatment period and follow-up period, pain intensity ratings were captured at the site visits in a patient reported-outcome system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent signed.\n* Male or female participant at least 18 years of age at Visit 1.\n* A diagnosis of complex regional pain syndrome according to the clinical diagnostic criteria recommended by the International Association for the Study of Pain (IASP; "Budapest clinical criteria"), assessed at Visit 1. Signs and symptoms of CRPS must apply to an affected limb (arm or leg) and must demonstrate asymmetry with respect to the contralateral limb.\n* Ongoing moderate to severe chronic pain, including a baseline current pain intensity score of greater than or equal to 4 using an 11-point Numerical Rating Scale, referring to the CRPS-affected limb, at Visit 2 (prior to dosing).\n* In stable treatment and follow-up therapy for CRPS for at least 1 month prior to allocation to treatment (Visit 2). Participants must have failed trials of at least 2 treatments for CRPS, one of which must be a pharmacologic treatment.\n* Women of child-bearing potential must have a negative urine beta-human chorionic gonadotropin (β-HCG) pregnancy test at Visit 1 and must be using 2 forms of medically acceptable contraception, including at least 1 highly effective method of contraception with a low failure rate, defined as less than 1% per year (e.g., oral contraceptives or intrauterine device), and a second medically acceptable method such as use of condoms with spermicide by their male partner. A barrier method alone is not acceptable. Highly effective methods of contraception must be used for at least 1 month prior to Visit 2 and for the duration of the trial.\n* Participants must be able to communicate meaningfully, be able to differentiate with regard to location and intensity of the pain, and be able to answer the questions in the questionnaires used in this trial (assistance in filling out the questionnaires may be provided, if required due to motor or other impairment).\n\nExclusion Criteria:\n\n* Evidence of renal impairment (estimated glomerular filtration rate \\[eGFR\\] less than 60 mL/min/1.73 m2 using the 2009 Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] creatinine equation \\[Levey et al. 2009\\] or a urinary albumin creatinine ratio greater than 150 mg/g), based on central safety laboratory data obtained prior to Visit 2, or a history of chronic kidney disease. Note: a single repeat laboratory test is allowed.\n* Serum calcium or magnesium outside of the central laboratory\'s reference range, based on central safety laboratory data obtained prior to Visit 2 (a single repeat laboratory test is allowed); a history of hypocalcemia or a metabolic disorder anticipated to increase risk for hypocalcemia (e.g., hypoparathyroidism); concomitant use of drug(s) with known potential to cause hypocalcemia (e.g., aminoglycosides).\n* Vitamin D deficiency, defined as a 25(OH)D level less than 30 ng/mL, based on central safety laboratory data obtained prior to Visit 2 (up to 4 repeat laboratory tests are allowed). Participants with vitamin D deficiency should receive appropriate supplementation during the enrollment period. A vitamin D level of at least 30 ng/mL must be documented prior to allocation to investigational medicinal product (IMP).\n* Corrected QT interval (according to Fridericia\'s formula; QTcF) greater than 470 ms (average of 3 electrocardiograms \\[ECGs\\] obtained at Visit 1); serum potassium outside the central laboratory\'s reference range at Visit 1; clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or an indwelling pacemaker; evidence of complete left bundle branch block; complete atrioventricular block; history of Long QT Syndrome or a relative with this condition; or any other known risk factor for torsade de pointes.\n* Participants receiving medications with a known risk of torsades de pointes within 7 days prior to allocation. Participants receiving selective serotonin re-uptake inhibitor antidepressants (e.g., citalopram, escitalopram) or tricyclic antidepressants are eligible if the QT-interval values do not meet the exclusion criteria, the medication was started at least 1 month prior to allocation, the dose is stable, and the dose is anticipated to remain stable until at least 4 days after the last infusion of IMP.\n* Anticipated requirement for treatment with oral or intravenous bisphosphonate for another condition such as osteoporosis during the trial, or administration of denosumab (Prolia®) or other drugs affecting bone turnover or bone metabolism within 6 months prior to Visit 1.\n* History of any allergic or hypersensitivity reaction to neridronic acid or other bisphosphonate, acetaminophen, or to vitamin D or calcium supplements.\n* Recent tooth extraction or other invasive dental procedure (within 3 months prior to Visit 1), unhealed or infected extraction site, or significant dental/periodontal disease (e.g., impacted molars, severe tooth decay, foci of infection) that may predispose to need for tooth extraction or other invasive dental procedures during the trial. Participants with indeterminate, suspicious or unreliable dental history, in the opinion of the investigator, must undergo a dental examination prior to receiving treatment.\n* Evidence of denture-related gum trauma or improperly fitting dentures causing injury.\n* Prior radiation therapy of the head or neck (within 1 year of Visit 1).\n* History of malignancy within 2 years prior to Visit 1, with the exception of basal cell carcinoma.\n* Use of nerve blocks, ketamine infusions, intravenous immunoglobulin, acupuncture, electromagnetic field treatment, or initiation/implementation of radiofrequency ablation or other sympathectomy procedures, or peripheral nerve stimulation within 6 weeks prior to Visit 2.\n* Evidence of current alcohol or drug abuse, or history of alcohol or drug abuse within 2 years of Visit 1, based on participant history and physical examination and according to the investigator\'s judgment.\n* Any other severe medical condition, including severe depression, or any other severe mood disorder, that in the opinion of the investigator may affect efficacy or safety assessments or may compromise the participant\'s safety during trial participation.\n* Women who are pregnant or breastfeeding.\n* Elevated aspartate aminotransferase or alanine aminotransferase greater than 2-fold upper limit of normal, based on central safety laboratory data obtained at Visit 1, or current evidence of chronic liver disease. Safety laboratory testing may be repeated prior to Visit 2, and participants will be allowed in the trial if results of 2 consecutive tests, at least 3 days apart, are less than or equal to 2-fold upper limit of normal.\n* Participation in another investigational drug trial within 3 months prior to Visit 1 or any previous trial with neridronic acid, with the exception of participants of KF7013-01 who were assigned to placebo and did not receive neridronic acid.\n* Participant is engaged in litigation related to their disability from CRPS in which monetary gain or loss (or other compensation) may affect their objective participation in the trial.\n* Participants taking forbidden concomitant medications/therapies or not being able to follow the rules of use of concomitant treatment.\n* Participants incapable of signing the informed consent.'}, 'identificationModule': {'nctId': 'NCT02972359', 'briefTitle': 'Safety of Intravenous Neridronic Acid in CRPS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Grünenthal GmbH'}, 'officialTitle': 'Open-label Safety Trial of Intravenous Neridronic Acid in Subjects With Complex Regional Pain Syndrome (CRPS)', 'orgStudyIdInfo': {'id': 'KF7013-03'}, 'secondaryIdInfos': [{'id': '2016-001164-11', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1180-8099', 'type': 'OTHER', 'domain': 'World Health Organization'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neridronic acid', 'description': 'Neridronic acid 100 mg administered on Day 1, Day 4, Day 7, and Day 10, resulting in a total dose of neridronic acid 400 mg.', 'interventionNames': ['Drug: Neridronic acid']}], 'interventions': [{'name': 'Neridronic acid', 'type': 'DRUG', 'description': 'Neridronic acid administered as intravenous infusion.', 'armGroupLabels': ['Neridronic acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'US017: Cactus Clinical 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'United States', 'facility': 'US031: Gold Coast Research, LLC', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'zip': '33603', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'US011: Clinical Research of West Florida, Inc.', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33409', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'US040: Palm Beach Research Center', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30265', 'city': 'Newnan', 'state': 'Georgia', 'country': 'United States', 'facility': 'US026: Better Health Clinical Research Inc.', 'geoPoint': {'lat': 33.38067, 'lon': -84.79966}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'US004: Northwestern University - Feinberg School of Medicine - Rehabilitation Institute of Chicago (RIC)', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 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