Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 11:28 PM
Study NCT ID:
NCT00375934
Status:
COMPLETED
Last Update Posted:
2010-09-21
First Post:
2006-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004008', 'term': 'Diclofenac'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials@xanodyne.com', 'phone': '1-877-926-6396', 'title': 'Steve Boesing', 'organization': 'Xanodyne Pharmaceuticals, Inc.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Zipsor (Diclofenac Potassium) Liquid Filled Capsule', 'description': '25 mg capsule, every 6 hours', 'otherNumAtRisk': 99, 'otherNumAffected': 46, 'seriousNumAtRisk': 99, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Oral placebo capsule, every 6 hours', 'otherNumAtRisk': 101, 'otherNumAffected': 63, 'seriousNumAtRisk': 101, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Feeling Hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nightmare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus generalized', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average Numeric Pain Rating Score (NPRS) Over 48 Hours After Bunionectomy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zipsor (Diclofenac Potassium) Liquid Filled Capsule', 'description': '25 mg capsule, every 6 hours'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral placebo capsule, every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Over 48 hours after bunionectomy', 'description': 'Pain intensity scores were measured using an 11-point numerical pain rating scale (NPRS) with 0=no pain to 10=worst possible pain', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Perceptible Pain Relief on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zipsor (Diclofenac Potassium) Liquid Filled Capsule', 'description': '25 mg capsule, every 6 hours'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral placebo capsule, every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 hours post single dose', 'description': 'Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zipsor (Diclofenac Potassium) Liquid Filled Capsule', 'description': '25 mg capsule, every 6 hours'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral placebo capsule, every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000', 'lowerLimit': '33.6', 'upperLimit': '53.3'}, {'value': '36.0', 'groupId': 'OG001', 'lowerLimit': '29.8', 'upperLimit': '60.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '8 hours post single dose', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes only the number of participants with perceptible pain relief on Day 1 (see previous outcome measure #2).'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Meaningful Pain Relief on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zipsor (Diclofenac Potassium) Liquid Filled Capsule', 'description': '25 mg capsule, every 6 hours'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral placebo capsule, every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 hours post single dose', 'description': 'Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Median Time to Onset of Pain Relief in Patients With Meaningful Pain Relief on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zipsor (Diclofenac Potassium) Liquid Filled Capsule', 'description': '25 mg capsule, every 6 hours'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral placebo capsule, every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '90.6', 'groupId': 'OG000', 'lowerLimit': '85.0', 'upperLimit': '119.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '8 hours post single dose', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes only the number of participants with meaningful pain relief on Day 1 (see previous outcome measure #4).\n\nNumber of patients in the placebo group is intentionally blank as the data (eg., median and upper CI) were not calculable (see post-hoc outcome measure #12 for available placebo results).'}, {'type': 'SECONDARY', 'title': 'Total Pain Relief (TOTPAR) Scores 8 Hours Post Initial Dose of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zipsor (Diclofenac Potassium) Liquid Filled Capsule', 'description': '25 mg capsule, every 6 hours'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral placebo capsule, every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '3.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 hourse post single dose', 'description': 'Pain relief was rated using a 5-point categorial scale (0=none, 1=a little, 2=some, 3=a lot, and 4=complete) at time of dose (time=0) and over 15 time points afterwards (10, 15, 20, 30, 45, and 60 minutes and at 1.5, 2, 2.5, 3, 4, 5, 6, 7, and 8 hours after the initial dose on Day 1 or until time of re-medication). A score of 0 across all time points would be the lowest (worst) and a score of 60 (4 X 15 time points) would be the highest (best) possible score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zipsor (Diclofenac Potassium) Liquid Filled Capsule', 'description': '25 mg capsule, every 6 hours'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral placebo capsule, every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 hours post single dose', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Onset of at Least 30% Reduction in Pain Intensity After First Dose of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zipsor (Diclofenac Potassium) Liquid Filled Capsule', 'description': '25 mg capsule, every 6 hours'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral placebo capsule, every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000', 'lowerLimit': '90', 'upperLimit': '147'}, {'value': '300', 'groupId': 'OG001', 'lowerLimit': '120', 'upperLimit': '300'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '8 hours post single dose', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes only the number of participants with at least 30% reduction in pain intensity after first dose of study drug (see previous outcome measure #7).'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Required Rescue Medication on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zipsor (Diclofenac Potassium) Liquid Filled Capsule', 'description': '25 mg capsule, every 6 hours'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral placebo capsule, every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Required Rescue Medication on Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zipsor (Diclofenac Potassium) Liquid Filled Capsule', 'description': '25 mg capsule, every 6 hours'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral placebo capsule, every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 2', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Required Rescue Medication on Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zipsor (Diclofenac Potassium) Liquid Filled Capsule', 'description': '25 mg capsule, every 6 hours'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral placebo capsule, every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 3', 'description': 'Day 3 data reflect the use of rescue medication only up to the time of discharge.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zipsor (Diclofenac Potassium) Liquid Filled Capsule', 'description': '25 mg capsule, every 6 hours'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Oral placebo capsule, every 6 hours'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}, {'groupId': 'FG001', 'numSubjects': '95'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Zipsor (Diclofenac Potassium) Liquid Filled Capsule', 'description': '25 mg capsule, every 6 hours'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Oral placebo capsule, every 6 hours'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41', 'spread': '13', 'groupId': 'BG000'}, {'value': '40', 'spread': '12', 'groupId': 'BG001'}, {'value': '40', 'spread': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Pain Score', 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '7.4', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '7.5', 'spread': '1.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Pain intensity scores were measured using an 11-point numerical pain rating scale (NPRS) with 0=no pain to 10=worst possible pain', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'statusVerifiedDate': '2010-05', 'lastUpdateSubmitDate': '2010-09-17', 'studyFirstSubmitDate': '2006-09-11', 'resultsFirstSubmitDate': '2010-03-22', 'studyFirstSubmitQcDate': '2006-09-11', 'lastUpdatePostDateStruct': {'date': '2010-09-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-05-24', 'studyFirstPostDateStruct': {'date': '2006-09-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Numeric Pain Rating Score (NPRS) Over 48 Hours After Bunionectomy', 'timeFrame': 'Over 48 hours after bunionectomy', 'description': 'Pain intensity scores were measured using an 11-point numerical pain rating scale (NPRS) with 0=no pain to 10=worst possible pain'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Perceptible Pain Relief on Day 1', 'timeFrame': '8 hours post single dose', 'description': 'Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.'}, {'measure': 'Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1', 'timeFrame': '8 hours post single dose'}, {'measure': 'Number of Patients With Meaningful Pain Relief on Day 1', 'timeFrame': '8 hours post single dose', 'description': 'Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.'}, {'measure': 'Median Time to Onset of Pain Relief in Patients With Meaningful Pain Relief on Day 1', 'timeFrame': '8 hours post single dose'}, {'measure': 'Total Pain Relief (TOTPAR) Scores 8 Hours Post Initial Dose of Study Drug', 'timeFrame': '8 hourse post single dose', 'description': 'Pain relief was rated using a 5-point categorial scale (0=none, 1=a little, 2=some, 3=a lot, and 4=complete) at time of dose (time=0) and over 15 time points afterwards (10, 15, 20, 30, 45, and 60 minutes and at 1.5, 2, 2.5, 3, 4, 5, 6, 7, and 8 hours after the initial dose on Day 1 or until time of re-medication). A score of 0 across all time points would be the lowest (worst) and a score of 60 (4 X 15 time points) would be the highest (best) possible score.'}, {'measure': 'Number of Patients With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug', 'timeFrame': '8 hours post single dose'}, {'measure': 'Time to Onset of at Least 30% Reduction in Pain Intensity After First Dose of Study Drug', 'timeFrame': '8 hours post single dose'}, {'measure': 'Number of Patients Who Required Rescue Medication on Day 1', 'timeFrame': 'Day 1'}, {'measure': 'Number of Patients Who Required Rescue Medication on Day 2', 'timeFrame': 'Day 2'}, {'measure': 'Number of Patients Who Required Rescue Medication on Day 3', 'timeFrame': 'Day 3', 'description': 'Day 3 data reflect the use of rescue medication only up to the time of discharge.'}]}, 'conditionsModule': {'keywords': ['Bunionectomy', 'Bunion surgery', 'Post-operative pain'], 'conditions': ['Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '22587481', 'type': 'DERIVED', 'citation': 'Daniels SE, Riff D, Diamond E, Clark F, Boesing SE. An assessment of the efficacy and safety of diclofenac potassium liquid-filled capsules in patients with various levels of baseline pain intensity. Curr Med Res Opin. 2012 Jun;28(6):953-61. doi: 10.1185/03007995.2012.694363. Epub 2012 Jun 11.'}, {'pmid': '20804444', 'type': 'DERIVED', 'citation': 'Daniels SE, Baum DR, Clark F, Golf MH, McDonnell ME, Boesing SE. Diclofenac potassium liquid-filled soft gelatin capsules for the treatment of postbunionectomy pain. Curr Med Res Opin. 2010 Oct;26(10):2375-84. doi: 10.1185/03007995.2010.515478.'}], 'seeAlsoLinks': [{'url': 'http://www.zipsor.com/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'A multicenter study to evaluate the analgesic efficacy of XP21L in subjects with pain following bunionectomy surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 years of age\n* Have undergone bunionectomy surgery\n* Have achieved adequate post-surgical pain\n\nExclusion Criteria:\n\n* Confounding medical conditions which preclude study participation\n* Participated in a study of another investigational drug or device within 30 days prior to randomization'}, 'identificationModule': {'nctId': 'NCT00375934', 'briefTitle': 'Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Xanodyne Pharmaceuticals'}, 'officialTitle': 'Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery', 'orgStudyIdInfo': {'id': 'XP21L-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: diclofenac potassium (XP21L)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'diclofenac potassium (XP21L)', 'type': 'DRUG', 'otherNames': ['Zipsor Liquid Filled Capsule', 'XP21L'], 'description': '25 mg capsule, every 6 hours', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral placebo capsule, every 6 hours', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77057', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78666', 'city': 'San Marcos', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 29.88327, 'lon': -97.94139}}, {'zip': '84117', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xanodyne Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Gary Shangold, M.D. / Chief Medical Officer', 'oldOrganization': 'Xanodyne Pharmaceuticals, Inc.'}}}}