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Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00800527
Recruitment Status : Completed
First Posted : December 2, 2008
Last Update Posted : December 2, 2008
Sponsor:
Information provided by:
Usak State Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chest Pain Paresthesia Drug: Gabapentin Drug: Diclofenac Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy
Study Start Date : November 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Gabapentin
 Drug: Gabapentin
Gabapentin 800 mg one a day up to 30 day
Other Name: Group-1: Gabapentin Arm
Active Comparator: 2
Diclofenac
 Drug: Diclofenac
Diclofenac 75 mg one a day up to 30 day
Other Name: Group-2: Diclofenac arm


Outcome Measures
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Primary Outcome Measures :
  1. Reduction of pain or paresthesia severity [ Time Frame: one month ]

Secondary Outcome Measures :
  1. duration of relief of pain or paresthesia [ Time Frame: three month ]

Eligibility Criteria
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Ages Eligible for Study:   15 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00800527


Locations
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Turkey
Usak State Hospital
Usak, Turkey, 64100
Sponsors and Collaborators
Usak State Hospital
Investigators
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Principal Investigator: Ismail BIYIK, MD Investigator
More Information
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Responsible Party: Ismail BIYIK, Investigator
ClinicalTrials.gov Identifier: NCT00800527    
Other Study ID Numbers: B4ISM4350015-009/295
First Posted: December 2, 2008    Key Record Dates
Last Update Posted: December 2, 2008
Last Verified: November 2008
Keywords provided by Usak State Hospital:
sternotomy
pain
paresthesia
Poststernotomy chest pain
Poststernotomy chest paresthesia
Additional relevant MeSH terms:
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Paresthesia
Chest Pain
Pain
Neurologic Manifestations
Somatosensory Disorders
Sensation Disorders
Nervous System Diseases
Diclofenac
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
 Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors