Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-27 @ 9:41 AM
Study NCT ID:
NCT03060434
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-21
First Post:
2017-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pentoxifylline and Lumbar Radiculopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011843', 'term': 'Radiculopathy'}, {'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}, {'id': 'C535531', 'term': 'Intervertebral disc disease'}, {'id': 'D012585', 'term': 'Sciatica'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020426', 'term': 'Sciatic Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010431', 'term': 'Pentoxifylline'}, {'id': 'D007052', 'term': 'Ibuprofen'}, {'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D000069583', 'term': 'Pregabalin'}], 'ancestors': [{'id': 'D013805', 'term': 'Theobromine'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The assessor and the investigator are unaware of the sequence of the 15 days treatment with pentoxifylline'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Each patient will receive for 1 month: Ibuprofen 600 mg bid; Paracetamol 1g tid if needed; pregabalin 75 mg bid pentoxifylline 400 mg bid will be added for either the first or second 15 days (randomization)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-18', 'studyFirstSubmitDate': '2017-02-18', 'studyFirstSubmitQcDate': '2017-02-18', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numerical rating scale (NRS)', 'timeFrame': 'At day 15 (and Day 30)', 'description': 'Pain assessment by NRS'}], 'secondaryOutcomes': [{'measure': 'Patient global impression of improvement scale', 'timeFrame': 'day 15 and 30', 'description': 'pain improvement scale from 1 to 7'}, {'measure': 'Side effects', 'timeFrame': 'Day 15 and 30', 'description': 'Reporting side effects by patient'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pentoxifylline', 'Disc hernia', 'sciatica', 'lumbar radiculopathy'], 'conditions': ['Lumbar Radiculopathy', 'Lumbar Disc Herniation', 'Lumbar Disc Disease']}, 'descriptionModule': {'briefSummary': 'The objective of this prospective controlled crossover study is to evaluate the efficacy and safety of pentoxifylline per os (800 mg daily) in the management of lumbar radiculopathy', 'detailedDescription': 'Patients with lumbar radiculopathy, are recruited from senior author clinic. After verification of inclusion and exclusion criteria, patients consenting to enter the study are given 2 sequences (order randomly assigned) of treatment: Ibuprofen 600 mg bid, with paracetamol 1000 mg tid, pregabalin 75 mg bid for 15 days with pentoxifylline and 15 days without it. Basic clinical and demographical data are noted. Lumbar MRI results are also noted. Clinical evaluation of the patient is performed and included: clinical examination (including motor exam of lower limbs); pain is assessed according to Numerical rating Scale (NRS), and relative percentage of global improvement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral lumbar radiculopathy\n* Disc hernia confirming the diagnosis with radio-clinical concordance\n\nExclusion Criteria:\n\n* Radicular deficit needing surgery\n* Cauda equine syndrome\n* Absence of radio-clinical concordance on MRI\n* Contraindication for anti-inflammatory (Hypertension, renal insufficiency, gastric ulcer …)\n* Previous intolerance to pentoxifylline, and/or to pregabalin and/or paracetamol\n* Pregnancy\n* Follow-up not possible\n* Hepatic dysfunction\n* History of drug abuse\n* Current use of tramadol, codeine and/or morphine and its derivative\n* Antidepressant use'}, 'identificationModule': {'nctId': 'NCT03060434', 'briefTitle': 'Pentoxifylline and Lumbar Radiculopathy', 'organization': {'class': 'OTHER', 'fullName': 'St Joseph University, Beirut, Lebanon'}, 'officialTitle': 'Prospective Controlled Crossover Study of the Role of Pentoxifylline in the Management of Lumbar Radiculopathy', 'orgStudyIdInfo': {'id': 'Pento-LR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Ibuprofen', 'interventionNames': ['Drug: Ibuprofen']}, {'type': 'EXPERIMENTAL', 'label': 'Pentoxifylline', 'description': 'Pentoxifylline oral tablets', 'interventionNames': ['Drug: Pentoxifylline Oral Tablet']}], 'interventions': [{'name': 'Pentoxifylline Oral Tablet', 'type': 'DRUG', 'otherNames': ['Ibuprofen', 'Paracetamol', 'pregabalin'], 'description': 'patient will receive for 15 days: Ibuprofen 600 mg bid; pregabalin 75 mg bid; paracetamol 1 g tid; pentoxifylline 400 mg bid', 'armGroupLabels': ['Pentoxifylline']}, {'name': 'Ibuprofen', 'type': 'DRUG', 'otherNames': ['Paracetamol', 'pregabalin'], 'description': 'patient will receive for 15 days: Ibuprofen 600 mg bid; pregabalin 75 mg bid; paracetamol 1 g tid', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16 6830', 'city': 'Beirut', 'country': 'Lebanon', 'facility': 'Hotel Dieu de France Hospital', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'overallOfficials': [{'name': 'Joseph Maarrawi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hotel Dieu de France Hospital - Beirut, Lebanon, 16 6830'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St Joseph University, Beirut, Lebanon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor : Researcher - Pain Specialist - Neurosurgeon', 'investigatorFullName': 'Dr Joseph Maarrawi', 'investigatorAffiliation': 'St Joseph University, Beirut, Lebanon'}}}}