Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-01-09 @ 10:28 PM
Study NCT ID:
NCT00671502
Status:
COMPLETED
Last Update Posted:
2011-11-09
First Post:
2008-05-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002328', 'term': 'Carisoprodol'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david.ginsberg@meda.us', 'phone': '732 564 2364', 'title': 'David Ginsberg, MD Sr Medical Director', 'organization': 'Meda Pharma US'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'up to 21 days', 'eventGroups': [{'id': 'EG000', 'title': 'Carisoprodol 700mg', 'description': 'tablet experimental formulation', 'otherNumAtRisk': 278, 'otherNumAffected': 78, 'seriousNumAtRisk': 278, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Carisoprodol 500mg Tablet', 'description': 'tablet experimental formulation', 'otherNumAtRisk': 280, 'otherNumAffected': 65, 'seriousNumAtRisk': 280, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Placebo Tablet', 'description': 'tablet placebo no experimental formulation', 'otherNumAtRisk': 275, 'otherNumAffected': 37, 'seriousNumAtRisk': 275, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 44, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 36, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 275, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 275, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 275, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 275, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 275, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA'}], 'seriousEvents': [{'term': 'transient ischemic attack', 'notes': 'occurred after discontinuation of drug therefore not considered treatment emergent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA'}], 'frequencyThreshold': '0.7'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subject Rating of Pain on a 100-point Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}, {'value': '279', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Carisoprodol 500mg Tablets', 'description': 'carisoprodol 500mg tablets treatment arm'}, {'id': 'OG001', 'title': 'Carisoprodol 700mg Tablets', 'description': 'carisoprodol 700mg tablets treatment arm'}, {'id': 'OG002', 'title': 'Placebo Tablets', 'description': 'placebo tablets treatment arm'}], 'classes': [{'categories': [{'measurements': [{'value': '27.5', 'groupId': 'OG000', 'lowerLimit': '-21', 'upperLimit': '83'}, {'value': '28', 'groupId': 'OG001', 'lowerLimit': '-19', 'upperLimit': '89'}, {'value': '28.6', 'groupId': 'OG002', 'lowerLimit': '-36', 'upperLimit': '82'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'up to 14 days', 'description': 'the scale used was from 0 to 100 mm. 0 equaled no pain and 100 equaled maximum pain.participants measure their pain before treatment and during treatment at each visit', 'unitOfMeasure': 'mm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'efficacy analyses based on ITT population. LOCF used to impute missing data. To detect a 14% difference between the carisoprodol and placebo treated subjects, 196 ITTsubjects per group (alpha level 0.025,power 80%).Assuming 15% dropout rate, 226 subjects per group were needed.A total of678 subjects were required to achieve 584 ITT subjects.'}, {'type': 'SECONDARY', 'title': 'Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)', 'timeFrame': 'up to 14 days', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Event Assessment', 'paramType': 'NUMBER', 'timeFrame': 'up to 21 days', 'description': 'the number of adverse events reported during the course of the study as reported by the participants', 'unitOfMeasure': 'participants', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Carisoprodol 700mg', 'description': 'tablet experimental formulation'}, {'id': 'FG001', 'title': 'Carisoprodol 500mg Tablet', 'description': 'tablet experimental formulation'}, {'id': 'FG002', 'title': 'Placebo Tablet', 'description': 'tablet placebo no experimental formulation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '281'}, {'groupId': 'FG001', 'numSubjects': '280'}, {'groupId': 'FG002', 'numSubjects': '279'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '242'}, {'groupId': 'FG001', 'numSubjects': '241'}, {'groupId': 'FG002', 'numSubjects': '252'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '27'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}, {'value': '280', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}, {'value': '840', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Carisoprodol 700mg', 'description': 'tablet experimental formulation'}, {'id': 'BG001', 'title': 'Carisoprodol 500mg Tablet', 'description': 'tablet experimental formulation'}, {'id': 'BG002', 'title': 'Placebo Tablet', 'description': 'tablet placebo no experimental formulation'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '278', 'groupId': 'BG000'}, {'value': '278', 'groupId': 'BG001'}, {'value': '275', 'groupId': 'BG002'}, {'value': '831', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.3', 'spread': '13.05', 'groupId': 'BG000'}, {'value': '41.4', 'spread': '12.6', 'groupId': 'BG001'}, {'value': '40.9', 'spread': '12.72', 'groupId': 'BG002'}, {'value': '40.9', 'spread': '12.78', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}, {'value': '413', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}, {'value': '427', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '281', 'groupId': 'BG000'}, {'value': '280', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}, {'value': '840', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 840}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-04', 'studyFirstSubmitDate': '2008-05-01', 'resultsFirstSubmitDate': '2011-06-28', 'studyFirstSubmitQcDate': '2008-05-01', 'lastUpdatePostDateStruct': {'date': '2011-11-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-10-04', 'studyFirstPostDateStruct': {'date': '2008-05-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subject Rating of Pain on a 100-point Visual Analog Scale (VAS)', 'timeFrame': 'up to 14 days', 'description': 'the scale used was from 0 to 100 mm. 0 equaled no pain and 100 equaled maximum pain.participants measure their pain before treatment and during treatment at each visit'}], 'secondaryOutcomes': [{'measure': 'Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)', 'timeFrame': 'up to 14 days'}, {'measure': 'Adverse Event Assessment', 'timeFrame': 'up to 21 days', 'description': 'the number of adverse events reported during the course of the study as reported by the participants'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lower Back Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if two sustained released formulations of carisoprodol are more effective than placebo.', 'detailedDescription': 'Methodology:\n\nThis was a randomized, double-blind, double-dummy, placebo-controlled, parallel-group study in subjects 18-70 years of age with acute, painful, muscle spasm of the lower back. The study consisted of a baseline screening (Study Day 1), during which subjects were evaluated for inclusion/exclusion criteria, and a 7-day double-blind treatment period (Study Day 1 through Study Day 7). Subjects were randomly assigned to be dosed twice daily with one of the following double-blind treatments: sustained release(SR) carisoprodol 500-mg tablets,sustained release (SR) carisoprodol 700-mg tablets, or placebo.\n\nSubjects were evaluated in the clinic on Study Days 1, 3 and 7. Subjects who remained symptomatic on Study Day 7 were allowed to continue in the study for a 7-day, double-blind extension period at the discretion of the Investigator. Subjects were contacted by telephone for a safety follow-up 7 days after the last dose of study medication.\n\nA pharmacokinetic (PK) substudy was conducted at selected sites. These sites obtained blood samples for PK analysis at the end of the 7-day treatment period and the 14-day treatment period, if applicable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Onset of pain is within 3 days of first visit\n* Subject rating of pain must be 40 mm or greater on visual analog scale( VAS)\n* Ability to discontinue all analgesics, non steroidal anti inflammatory drug (NSAIDs), and other muscle relaxants\n* Willingness to provide written informed consent\n* Must be in generally good health\n\nExclusion Criteria:\n\n* Presence of sciatic pain\n* History of clinically significant spine pathology such as herniated nucleas pulposis, spondylolisthesis, spinal stenosis\n* Presence of underlying chronic back pain\n* Neurological signs and symptoms such as numbness, tingling, foot drop, parethesia, unexplained constipation, urinary retention or urinary incontinence\n* Myocardial infaction within one year of study\n* Cancer not in remission or in remission less than one year\n* HIV or other immunodeficiency syndromes\n* History of osteoporosis or at high risk for vetebral fracture\n* Underlying rheumatologic disease such as rheumatoid arthritis, ankylosing spondylitis, etc.\n* Presence of active influenze or other viral syndromes\n* Morbid obesity basal metabolic index(BMI \\>39)\n* Evidence of infection, such as low grade fever or neutrophilia\n* Existence of any medical/surgical condition that could interfere with the evaluation of the study medication\n* Known history of alcohol or drug abuse\n* Injury involving high potential for litigation, including worker's compensation or automobile accidents\n* Pregnancy or breast feeding\n* Women of child-bearing potential not abstinent or not practicing a medically acceptable method of contraception\n* Vertebral body or spinous process, percussive tenderness on physical exam\n* Any abnormalities in the following tests of both lower extremities: ankle dorsiflexion strength, great toe dorsiflexion strength, absent or hypereflexic Achilles or patellar tendor reflexes, abnormal sensory exam in the medial, dorsal or lateral aspect of the foot and positive straight leg raise test\n* Urgent medical conditions on comprehensive exam that might indicate a more serious condition should be treated urgently"}, 'identificationModule': {'nctId': 'NCT00671502', 'briefTitle': 'A Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back', 'organization': {'class': 'INDUSTRY', 'fullName': 'Meda Pharmaceuticals'}, 'officialTitle': 'Randomized, Double-Blind, Double-Dummy Trial of Two Sustained Release Formulations of Carisoprodol Compared to Placebo in Subjects With Acute, Painful, Musculoskeletal Spasm of the Lower Back', 'orgStudyIdInfo': {'id': 'MP510'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Carisoprodol 700mg', 'description': 'tablet sustained release (SR)', 'interventionNames': ['Drug: Carisoprodol SR']}, {'type': 'EXPERIMENTAL', 'label': 'Carisoprodol 500mg', 'description': 'sustained release(SR) tablet', 'interventionNames': ['Drug: Carisoprodol SR']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'tablet', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Carisoprodol SR', 'type': 'DRUG', 'otherNames': ['sustained release(SR)'], 'description': '700 mg twice daily', 'armGroupLabels': ['Carisoprodol 700mg']}, {'name': 'Carisoprodol SR', 'type': 'DRUG', 'otherNames': ['sustained release(SR) tablet'], 'description': '500 mg twice daily', 'armGroupLabels': ['Carisoprodol 500mg']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['no other name'], 'description': 'Placebo tablet', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35235', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'MedSearch, LLC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35802', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Genesis Clinical Research Corporation', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '36117', 'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'facility': 'Vaughn H. Mancha, Jr., PC Family Practice', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Anasazi Internal Medicine PC', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Heritage Physician Group', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'OrthoArkansas', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72114', 'city': 'North Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Family Practice Clinic', 'geoPoint': {'lat': 34.76954, 'lon': -92.26709}}, {'zip': '90716', 'city': 'Hawaiian Gardens', 'state': 'California', 'country': 'United States', 'facility': 'Quality of Life Medical Center, LLC', 'geoPoint': {'lat': 33.8314, 'lon': -118.07284}}, {'zip': 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