Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Chest Pain Paresthesia |
Intervention | Drug: Gabapentin Drug: Diclofenac |
Phase | Phase 4 |
Sponsor | Usak State Hospital |
Responsible Party | Usak State Hospital |
ClinicalTrials.gov Identifier | NCT00800527 |
First Received | November 28, 2008 |
Last Updated | December 1, 2008 |
Last verified | November 2008 |
Tracking Information[ + expand ][ + ]
First Received Date | November 28, 2008 |
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Last Updated Date | December 1, 2008 |
Start Date | November 2007 |
Estimated Primary Completion Date | October 2008 |
Current Primary Outcome Measures | Reduction of pain or paresthesia severity [Time Frame: one month] [Designated as safety issue: No] |
Current Secondary Outcome Measures | duration of relief of pain or paresthesia [Time Frame: three month] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
Brief Title | Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy |
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Official Title | Phase 4 Study of Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy |
Brief Summary | 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. |
Detailed Description | 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. |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition |
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Intervention | Drug: Gabapentin Gabapentin 800 mg one a day up to 30 day Other Names: Group-1: Gabapentin ArmDrug: Diclofenac Diclofenac 75 mg one a day up to 30 day Other Names: Group-2: Diclofenac arm |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 110 |
Estimated Completion Date | October 2008 |
Estimated Primary Completion Date | June 2008 |
Eligibility Criteria | Inclusion Criteria: - Poststernotomy chest pain and/or paresthesia Exclusion Criteria: - Osteoporosis, renal function impairment (creatinine value >1.5 mg / dl.) - Hepatic dysfunction, peptic ulcer, chest pain with ischemic origin, pediatric cases - Over production of scar tissue, thoracic surgery other than sternotomy - - Redo-bypass surgery, infection, sternal dehiscence,valve surgery together with bypass |
Gender | Both |
Ages | 15 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Turkey |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00800527 |
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Other Study ID Numbers | B4ISM4350015-009/295 |
Has Data Monitoring Committee | No |
Information Provided By | Usak State Hospital |
Study Sponsor | Usak State Hospital |
Collaborators | Not Provided |
Investigators | Principal Investigator: Ismail BIYIK, MD Investigator |
Verification Date | November 2008 |
Locations[ + expand ][ + ]
Usak State Hospital | Usak, Turkey, 64100 |
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