Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-29 @ 11:30 PM
Study NCT ID:
NCT00800527
Status:
COMPLETED
Last Update Posted:
2008-12-02
First Post:
2008-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010292', 'term': 'Paresthesia'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020886', 'term': 'Somatosensory Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077206', 'term': 'Gabapentin'}, {'id': 'D004008', 'term': 'Diclofenac'}], 'ancestors': [{'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D010648', 'term': 'Phenylacetates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-01', 'studyFirstSubmitDate': '2008-11-28', 'studyFirstSubmitQcDate': '2008-12-01', 'lastUpdatePostDateStruct': {'date': '2008-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of pain or paresthesia severity', 'timeFrame': 'one month'}], 'secondaryOutcomes': [{'measure': 'duration of relief of pain or paresthesia', 'timeFrame': 'three month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sternotomy', 'pain', 'paresthesia', 'Poststernotomy chest pain', 'Poststernotomy chest paresthesia'], 'conditions': ['Chest Pain', 'Paresthesia']}, 'descriptionModule': {'briefSummary': 'In this study, the investigators aim to demonstrate the efficacy of gabapentin compared with diclofenac in the treatment of chronic non-ischemic chest pain and paresthesia of the patients with sternotomy and to elucidate the similarities of PCPP to neuropathic pain syndromes.', 'detailedDescription': 'Because the primary objective of this study is to evaluate the effect of different drugs on chest pain and paresthesia, we choose the prospective, randomized, open label, blinded end point design for this study. According to this design, both patients and physicians making first assessment are aware of the treatment but the investigators making second and third assessment are blinded to treatment. Therefore, two separate cardiovascular surgeons wil select and randomize the patients and a cardiologist blinded to treatment assignments will evaluate the patients at second interview at thirty day and 3 months later. The study was approved by the Local Ethics Committee and informed consent was obtained from each patient. The study was conducted in Usak State Hospital with collaboration the Department of Cardiology of Ataturk Education and Training Hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Poststernotomy chest pain and/or paresthesia\n\nExclusion Criteria:\n\n* Osteoporosis, renal function impairment (creatinine value \\>1.5 mg / dl.)\n* Hepatic dysfunction, peptic ulcer, chest pain with ischemic origin, pediatric cases\n* Over production of scar tissue, thoracic surgery other than sternotomy -\n* Redo-bypass surgery, infection, sternal dehiscence,valve surgery together with bypass'}, 'identificationModule': {'nctId': 'NCT00800527', 'briefTitle': 'Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy', 'organization': {'class': 'OTHER', 'fullName': 'Usak State Hospital'}, 'officialTitle': 'Phase 4 Study of Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy', 'orgStudyIdInfo': {'id': 'B4ISM4350015-009/295'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Gabapentin', 'interventionNames': ['Drug: Gabapentin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Diclofenac', 'interventionNames': ['Drug: Diclofenac']}], 'interventions': [{'name': 'Gabapentin', 'type': 'DRUG', 'otherNames': ['Group-1: Gabapentin Arm'], 'description': 'Gabapentin 800 mg one a day up to 30 day', 'armGroupLabels': ['1']}, {'name': 'Diclofenac', 'type': 'DRUG', 'otherNames': ['Group-2: Diclofenac arm'], 'description': 'Diclofenac 75 mg one a day up to 30 day', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64100', 'city': 'Uşak', 'country': 'Turkey (Türkiye)', 'facility': 'Usak State Hospital', 'geoPoint': {'lat': 38.67351, 'lon': 29.4058}}], 'overallOfficials': [{'name': 'Ismail BIYIK, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Investigator'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Usak State Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Ismail BIYIK', 'oldOrganization': 'Investigator'}}}}