Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT01461369
Status:
COMPLETED
Last Update Posted:
2014-05-26
First Post:
2011-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Diclofenac Capsules to Treat Osteoarthritis Pain
Sponsor:
Organization:
Raw JSON
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'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Hepatic cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Metastases to lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Metastatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Hemiplegic migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac 35 mg Two Times Daily', 'description': 'Diclofenac (two times daily): Capsules'}, {'id': 'OG001', 'title': 'Diclofenac 35 mg Three Times Daily', 'description': 'Diclofenac (three times daily): Capsules'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: Capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '-39.04', 'spread': '2.905', 'groupId': 'OG000'}, {'value': '-44.14', 'spread': '3.070', 'groupId': 'OG001'}, {'value': '-32.46', 'spread': '2.937', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0024', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.68', 'ciLowerLimit': '-19.17', 'ciUpperLimit': '-4.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.806', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0795', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.58', 'ciLowerLimit': '-13.94', 'ciUpperLimit': '0.78', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.739', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12/Early Termination', 'description': 'The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain".\n\nThe WOMAC pain subscale score difference is calculated as the WOMAC pain subscale score assessed at Week 12 minus the WOMAC pain subscale score assessed at baseline.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac 35 mg Two Times Daily', 'description': 'Diclofenac (two times daily): Capsules'}, {'id': 'OG001', 'title': 'Diclofenac 35 mg Three Times Daily', 'description': 'Diclofenac (three times daily): Capsules'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: Capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '-31.40', 'spread': '2.742', 'groupId': 'OG000'}, {'value': '-37.42', 'spread': '2.907', 'groupId': 'OG001'}, {'value': '-21.60', 'spread': '2.787', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.82', 'ciLowerLimit': '-22.82', 'ciUpperLimit': '-8.83', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.552', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0052', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.80', 'ciLowerLimit': '-16.66', 'ciUpperLimit': '-2.95', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.481', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 2', 'description': 'The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain".\n\nThe WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 2 minus the WOMAC pain subscale score assessed at baseline.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac 35 mg Two Times Daily', 'description': 'Diclofenac (two times daily): Capsules'}, {'id': 'OG001', 'title': 'Diclofenac 35 mg Three Times Daily', 'description': 'Diclofenac (three times daily): Capsules'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: Capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '-36.64', 'spread': '2.889', 'groupId': 'OG000'}, {'value': '-43.51', 'spread': '3.051', 'groupId': 'OG001'}, {'value': '-31.08', 'spread': '2.922', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0011', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.43', 'ciLowerLimit': '-19.87', 'ciUpperLimit': '-4.99', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.776', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1349', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.56', 'ciLowerLimit': '-12.86', 'ciUpperLimit': '1.74', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.707', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 6', 'description': 'The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain".\n\nThe WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 6 minus the WOMAC pain subscale score assessed at baseline.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac 35 mg Two Times Daily', 'description': 'Diclofenac (two times daily): Capsules'}, {'id': 'OG001', 'title': 'Diclofenac 35 mg Three Times Daily', 'description': 'Diclofenac (three times daily): Capsules'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: Capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '-35.62', 'spread': '2.633', 'groupId': 'OG000'}, {'value': '-41.38', 'spread': '2.796', 'groupId': 'OG001'}, {'value': '-28.14', 'spread': '2.647', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.24', 'ciLowerLimit': '-19.89', 'ciUpperLimit': '-6.59', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.377', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0248', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.48', 'ciLowerLimit': '-14.00', 'ciUpperLimit': '-0.96', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.313', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12/Early Termination', 'description': 'The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain".\n\nThe WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Weeks 2, 6, and 12 minus the average of the WOMAC pain subscale score assessed at baseline.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total (Composite) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac 35 mg Two Times Daily', 'description': 'Diclofenac (two times daily): Capsules'}, {'id': 'OG001', 'title': 'Diclofenac 35 mg Three Times Daily', 'description': 'Diclofenac (three times daily): Capsules'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: Capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '-30.25', 'spread': '2.632', 'groupId': 'OG000'}, {'value': '-35.86', 'spread': '2.798', 'groupId': 'OG001'}, {'value': '-23.22', 'spread': '2.656', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.63', 'ciLowerLimit': '-19.32', 'ciUpperLimit': '-5.94', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.396', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0363', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.03', 'ciLowerLimit': '-13.60', 'ciUpperLimit': '-0.45', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.339', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12/Early Termination', 'description': 'Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total (composite) WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing "No Pain, Stiffness, or Difficulty" and 100 mm representing "Extreme Pain, Stiffness, and Difficulty".\n\nThe total (composite) WOMAC score difference was calculated as the total (composite) WOMAC score assessed at Weeks 2, 6, and 12 minus the total (composite) WOMAC score assessed at baseline.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the times specified.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac 35 mg Two Times Daily', 'description': 'Diclofenac (two times daily): Capsules'}, {'id': 'OG001', 'title': 'Diclofenac 35 mg Three Times Daily', 'description': 'Diclofenac (three times daily): Capsules'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: Capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '-36.41', 'spread': '2.670', 'groupId': 'OG000'}, {'value': '-41.33', 'spread': '2.830', 'groupId': 'OG001'}, {'value': '-30.95', 'spread': '2.690', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0028', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.38', 'ciLowerLimit': '-17.16', 'ciUpperLimit': '-3.60', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.441', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1081', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.46', 'ciLowerLimit': '-12.13', 'ciUpperLimit': '1.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.385', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12/Early Termination', 'description': 'The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Pain Imaginable".\n\nThe VAS pain intensity difference is calculated as the average of the VAS pain intensity scores at Weeks 2, 6, and 12 minus the VAS pain intensity at baseline.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the times specified.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Diclofenac 35 mg Two Times Daily', 'description': 'Diclofenac (two times daily): Capsules'}, {'id': 'FG001', 'title': 'Diclofenac 35 mg Three Times Daily', 'description': 'Diclofenac (three times daily): Capsules'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo: Capsule'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '98'}, {'groupId': 'FG002', 'numSubjects': '103'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '81'}, {'groupId': 'FG002', 'numSubjects': '86'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}, {'value': '305', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Diclofenac 35 mg Two Times Daily', 'description': 'Diclofenac (two times daily): Capsules'}, {'id': 'BG001', 'title': 'Diclofenac 35 mg Three Times Daily', 'description': 'Diclofenac (three times daily): Capsules'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo: Capsule'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.4', 'spread': '8.33', 'groupId': 'BG000'}, {'value': '61.7', 'spread': '9.90', 'groupId': 'BG001'}, {'value': '61.8', 'spread': '8.42', 'groupId': 'BG002'}, {'value': '61.6', 'spread': '8.87', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '203', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '288', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}]}, {'title': 'White or Caucasian', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '245', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Subjects were allowed to select more than one race; therefore, some subjects are counted multiple times.', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '88.16', 'spread': '17.037', 'groupId': 'BG000'}, {'value': '89.35', 'spread': '16.552', 'groupId': 'BG001'}, {'value': '89.44', 'spread': '17.991', 'groupId': 'BG002'}, {'value': '88.97', 'spread': '17.167', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '169.91', 'spread': '10.561', 'groupId': 'BG000'}, {'value': '167.60', 'spread': '9.794', 'groupId': 'BG001'}, {'value': '168.70', 'spread': '9.245', 'groupId': 'BG002'}, {'value': '168.76', 'spread': '9.898', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '30.6', 'spread': '5.18', 'groupId': 'BG000'}, {'value': '31.8', 'spread': '5.09', 'groupId': 'BG001'}, {'value': '31.3', 'spread': '5.18', 'groupId': 'BG002'}, {'value': '31.2', 'spread': '5.16', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score', 'classes': [{'categories': [{'measurements': [{'value': '73.42', 'spread': '15.22', 'groupId': 'BG000'}, {'value': '76.18', 'spread': '14.15', 'groupId': 'BG001'}, {'value': '75.27', 'spread': '17.27', 'groupId': 'BG002'}, {'value': '74.93', 'spread': '15.61', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The pain in subjects with osteoarthritis was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the mean of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level within the past 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain".', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Total (Composite) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Sc', 'classes': [{'categories': [{'measurements': [{'value': '70.26', 'spread': '15.69', 'groupId': 'BG000'}, {'value': '72.83', 'spread': '15.87', 'groupId': 'BG001'}, {'value': '71.60', 'spread': '17.24', 'groupId': 'BG002'}, {'value': '71.54', 'spread': '16.27', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The pain, stiffness, and physical function in subjects with osteoarthritis were measured at baseline using the total (composite) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale. The total WOMAC score is the average of the mean visual analogue scale scores, with 0 mm meaning "No Limitation" and 100 mm meaning "Extreme Limitation".\n\nBaseline total (composite) WOMAC score was calculated for 100 subjects in the Diclofenac Test Capsules two times daily group, 94 subjects in the Diclofenac Test Capsules three times daily group, and 100 subjects in the placebo group.', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Pain Intensity Visual Analogue Scale Score', 'classes': [{'categories': [{'measurements': [{'value': '69.6', 'spread': '19.99', 'groupId': 'BG000'}, {'value': '71.8', 'spread': '19.33', 'groupId': 'BG001'}, {'value': '71.5', 'spread': '18.82', 'groupId': 'BG002'}, {'value': '71.0', 'spread': '19.35', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain".\n\nThe Baseline Pain Intensity VAS score was calculated for 100 subjects in the Diclofenac Test Capsules two times daily group, 94 subjects in the Diclofenac Test Capsules three times daily group, and 100 subjects in the placebo group.', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 305}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-29', 'studyFirstSubmitDate': '2011-10-26', 'resultsFirstSubmitDate': '2014-03-12', 'studyFirstSubmitQcDate': '2011-10-26', 'lastUpdatePostDateStruct': {'date': '2014-05-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-29', 'studyFirstPostDateStruct': {'date': '2011-10-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.', 'timeFrame': 'Baseline to Week 12/Early Termination', 'description': 'The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain".\n\nThe WOMAC pain subscale score difference is calculated as the WOMAC pain subscale score assessed at Week 12 minus the WOMAC pain subscale score assessed at baseline.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.', 'timeFrame': 'Baseline to Week 2', 'description': 'The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain".\n\nThe WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 2 minus the WOMAC pain subscale score assessed at baseline.'}, {'measure': 'Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.', 'timeFrame': 'Baseline to Week 6', 'description': 'The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain".\n\nThe WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 6 minus the WOMAC pain subscale score assessed at baseline.'}, {'measure': 'Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.', 'timeFrame': 'Baseline to Week 12/Early Termination', 'description': 'The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain".\n\nThe WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Weeks 2, 6, and 12 minus the average of the WOMAC pain subscale score assessed at baseline.'}, {'measure': 'Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total (Composite) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.', 'timeFrame': 'Baseline to Week 12/Early Termination', 'description': 'Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total (composite) WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing "No Pain, Stiffness, or Difficulty" and 100 mm representing "Extreme Pain, Stiffness, and Difficulty".\n\nThe total (composite) WOMAC score difference was calculated as the total (composite) WOMAC score assessed at Weeks 2, 6, and 12 minus the total (composite) WOMAC score assessed at baseline.'}, {'measure': 'Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale.', 'timeFrame': 'Baseline to Week 12/Early Termination', 'description': 'The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Pain Imaginable".\n\nThe VAS pain intensity difference is calculated as the average of the VAS pain intensity scores at Weeks 2, 6, and 12 minus the VAS pain intensity at baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '25050589', 'type': 'DERIVED', 'citation': 'Gibofsky A, Hochberg MC, Jaros MJ, Young CL. Efficacy and safety of low-dose submicron diclofenac for the treatment of osteoarthritis pain: a 12 week, phase 3 study. Curr Med Res Opin. 2014 Sep;30(9):1883-93. doi: 10.1185/03007995.2014.946123. Epub 2014 Aug 6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Diclofenac \\[Test\\] Capsules are safe and effective for the treatment of osteoarthritis pain of the hip or knee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary diagnosis of Functional Class I-III OA of the hip or knee with documented osteoarthritis flare at baseline\n* Chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for OA pain\n* Discontinued all analgesic therapy at Screening\n* For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control\n\nExclusion Criteria:\n\n* History of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any NSAIDS, including diclofenac\n* Requires continuous use of opioid or opioid combination products to control OA pain of the knee or hip\n* Clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease\n* Significant difficulties swallowing capsules or unable to tolerate oral medication\n* Previous participation in another clinical study of Diclofenac Capsules or received any investigational drug or device or investigational therapy within 30 days before Screening.'}, 'identificationModule': {'nctId': 'NCT01461369', 'briefTitle': 'Study of Diclofenac Capsules to Treat Osteoarthritis Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Iroko Pharmaceuticals, LLC'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Parallel-Group, Efficacy and Safety Study of Diclofenac [Test] Capsules in Subjects With Osteoarthritis of the Knee or Hip', 'orgStudyIdInfo': {'id': 'DIC3-08-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diclofenac Capsules 35 mg bid', 'interventionNames': ['Drug: Diclofenac']}, {'type': 'EXPERIMENTAL', 'label': 'Diclofenac Capsules 35 mg tid', 'interventionNames': ['Drug: Diclofenac']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Capsule', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Diclofenac', 'type': 'DRUG', 'description': '35 mg bid Capsules', 'armGroupLabels': ['Diclofenac Capsules 35 mg bid']}, {'name': 'Diclofenac', 'type': 'DRUG', 'description': '35 mg tid Capsules', 'armGroupLabels': ['Diclofenac Capsules 35 mg tid']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Capsules', 'armGroupLabels': ['Placebo Capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85027', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Premier Research Group - Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Lynn Institute of the Ozarks', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Acri-Phase I, LLC', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '95608', 'city': 'Carmichael', 'state': 'California', 'country': 'United States', 'facility': 'Med Center', 'geoPoint': {'lat': 38.61713, 'lon': -121.32828}}, {'zip': '80909', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Expresscare Clinical Research', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '32205', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Westside Center for Clinical Research', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Jacksonville Center for Clinical Research', 'geoPoint': {'lat': 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'facility': 'Clinical Investigation Specialists, Inc', 'geoPoint': {'lat': 42.3703, 'lon': -87.90202}}, {'zip': '67114', 'city': 'Newton', 'state': 'Kansas', 'country': 'United States', 'facility': 'Heartland Research Associates, LLC', 'geoPoint': {'lat': 38.04668, 'lon': -97.34504}}, {'zip': '66206', 'city': 'Prairie Village', 'state': 'Kansas', 'country': 'United States', 'facility': 'Clinical Trials Technology Inc', 'geoPoint': {'lat': 38.99167, 'lon': -94.63357}}, {'zip': '67203', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Professional Research Network of Kansas, LLC', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '41017', 'city': 'Crestview Hills', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Community Research', 'geoPoint': {'lat': 39.02728, 'lon': -84.58494}}, {'zip': '48025', 'city': 'Bingham Farms', 'state': 'Michigan', 'country': 'United States', 'facility': 'Quest Research Institute', 'geoPoint': {'lat': 42.51587, 'lon': -83.27326}}, {'zip': '63031', 'city': 'Florissant', 'state': 'Missouri', 'country': 'United States', 'facility': 'Healthcare Research', 'geoPoint': {'lat': 38.78922, 'lon': -90.32261}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Sundance Clinical Research, LLC', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68134', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Heartland Clinical Research, Inc', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '68134', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Meridian Clinical Research', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89106', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Office of Matthew Barton, MD', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '10530', 'city': 'Hartsdale', 'state': 'New York', 'country': 'United 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