Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-04-02 @ 1:56 AM
Study NCT ID:
NCT00640432
Status:
COMPLETED
Last Update Posted:
2021-02-02
First Post:
2008-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety And Efficacy Of Celecoxib Versus Sodium Diclofenac In The Treatment Of Acute Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D004008', 'term': 'Diclofenac'}, {'id': 'D000068579', 'term': 'Celecoxib'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 244}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2004-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-29', 'studyFirstSubmitDate': '2008-03-17', 'studyFirstSubmitQcDate': '2008-03-20', 'lastUpdatePostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-03-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in patient-rated visual analogue scale (VAS) pain intensity assessment', 'timeFrame': 'Day 3'}], 'secondaryOutcomes': [{'measure': "Subject's quality of life, as measured by the SF-36 Health Survey", 'timeFrame': 'Day 7'}, {'measure': 'Physical examination', 'timeFrame': 'Days 3 and 7'}, {'measure': 'Pain relief score', 'timeFrame': 'Days 3 and 7'}, {'measure': 'Vital signs', 'timeFrame': 'Days 3 and 7'}, {'measure': 'Adverse events', 'timeFrame': 'Days 3 and 7'}, {'measure': 'Change from baseline in VAS pain intensity assessment', 'timeFrame': 'Day 7'}, {'measure': 'Categorical pain intensity score', 'timeFrame': 'Days 3 and 7'}, {'measure': "Subject's global assessment score", 'timeFrame': 'Days 3 and 7'}, {'measure': 'Subject\'s functional ability, as measured by the "Roland Morris" Questionnaire about low back pain and disability', 'timeFrame': 'Day 7'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3191064&StudyName=Safety%20And%20Efficacy%20Of%20Celecoxib%20Versus%20Sodium%20Diclofenac%20In%20The%20Treatment%20Of%20Acute%20Low%20Back%20Pain', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and efficacy of celecoxib versus sodium diclofenac in subjects with acute low back pain'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Aged between 18 and 65 years\n* Acute low back pain that falls into 1st or 2nd class of 'Quebec Task Force' classification of moderate to severe intensity (\\>50 mm in the VAS)\n* Acute low back pain onset \\<72 hours prior to study inclusion and \\>6 weeks after the last acute low back pain episode\n\nExclusion criteria:\n\n* Scoliosis or known history of inflammatory arthritis, chronic pain, metastasis, Paget's disease, or any other disease that cause pain\n* Low back pain from major trauma or visceral disorder\n* Esophageal ulcers, gastric or duodenal ulcers or bleeding within 30 days prior to being administered study drug"}, 'identificationModule': {'nctId': 'NCT00640432', 'briefTitle': 'Safety And Efficacy Of Celecoxib Versus Sodium Diclofenac In The Treatment Of Acute Low Back Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of The Safety, Tolerability And Efficacy Of Celecoxib 200 Mg Twice A Day (With A 400 Mg Attack Dose) Versus Sodium Diclofenac 75 Mg Twice A Day In Subjects With Acute Low Back Pain', 'orgStudyIdInfo': {'id': 'A3191064'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'interventionNames': ['Drug: Diclofenac']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'interventionNames': ['Drug: Celecoxib']}], 'interventions': [{'name': 'Diclofenac', 'type': 'DRUG', 'description': '75 mg oral capsule twice daily for 7 days', 'armGroupLabels': ['A']}, {'name': 'Celecoxib', 'type': 'DRUG', 'description': '400 mg oral capsule followed by 200 mg oral capsule with the evening meal (\\>=4 hours from first dose) on Day 1 then 200 mg oral capsule twice daily for 6 days', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40420-000', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'zip': '74043-110', 'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'zip': '74075-020', 'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'zip': '74605-050', 'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'zip': '86010-010', 'city': 'Londrina', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -23.31028, 'lon': -51.16278}}, {'zip': '21215-020', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '21941-590', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '04039-004', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '08270-070', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Pfizer's Upjohn has merged with Mylan to form Viatris Inc.", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}