Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT00308594
Status:
TERMINATED
Last Update Posted:
2011-04-28
First Post:
2006-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Dexamethasone for the Treatment of Cervical Radiculopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011843', 'term': 'Radiculopathy'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'whyStopped': 'Study terminated due to withdrawl of participating co-investigators.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-27', 'studyFirstSubmitDate': '2006-03-28', 'studyFirstSubmitQcDate': '2006-03-28', 'lastUpdatePostDateStruct': {'date': '2011-04-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neck Disability Index'}], 'secondaryOutcomes': [{'measure': 'Visual Numeric Scale for arm & neck pain'}, {'measure': 'Days missed from work'}, {'measure': 'Cervical Radiculopathy Neurologic Impairment Scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cervical radiculopathy', 'dexamethasone', 'corticosteroid', 'oral'], 'conditions': ['Cervical Radiculopathy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether dexamethasone is effective in the treatment of pain and disability resulting from a compressed spinal nerve in the neck (cervical radiculopathy).', 'detailedDescription': 'Cervical radiculopathy is causes both short and long term pain and diability. The current proven treatments include pain killers or surgery if there if patients experience progressive weakness or signs or spinal cord compression. Observations in both animal models and humans indicate that there is an inflammatory component to it. Corticosteroids (such as dexamethasone)are potent anti-inflammatories which may benefit people suffering from this condition. There is some evidence to support neck injections of drug directly onto the nerve root. This mmethod of drug delivery has been implicated with some serious complications such as paralysis and stroke. Delivering these medications in a pill form may provide a similar benefit without some of the serious complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18 - 60\n* arm and neck pain consistent with cervical radiculopathy\n* Neck Disability Index score of at least 15 (moderate)\n* symptom onset between 2 weeks and 6 months prior to enrollment\n\nExclusion Criteria:\n\n* Actively immunosuppressed state\n* clinical red flags consistent with possible infection or malignancy\n* acute febrile illness or infection requiring antibiotics\n* upper motor neuron signs consistent with myelopathy\n* previous orthopedic neck surgery in the area of that nerve root\n* known hepatic dysfunction\n* schizophrenia\n* pregnancy/nursing mothers\n* previous chronic corticosteroid use\n* diabetes mellitus on treatment\n* rapidly improving course\n* osteoporosis\n* hypersensitivity to product components\n* systemic fungal infection\n* recent administration of live vaccine\n* active tuberculosis\n* glaucoma\n* peptic ulcer disease'}, 'identificationModule': {'nctId': 'NCT00308594', 'briefTitle': 'Oral Dexamethasone for the Treatment of Cervical Radiculopathy', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'Oral Dexamethasone for the Treatment of Cervical Radiculopathy: A Double Blinded, Randomized, Placebo Controlled Trial', 'orgStudyIdInfo': {'id': 'B2006:027'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Dave R Hooper, MD BSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manitoba'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}}}}