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

December 1, 2008 updated by: Usak State Hospital

Phase 4 Study of Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

110

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Usak, Turkey, 64100
        • Usak State Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Gabapentin
Drug: Gabapentin
Gabapentin 800 mg one a day up to 30 day
Other Names:
  • Group-1: Gabapentin Arm
Active Comparator: 2
Diclofenac
Drug: Diclofenac
Diclofenac 75 mg one a day up to 30 day
Other Names:
  • Group-2: Diclofenac arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of pain or paresthesia severity
Time Frame: one month
one month

Secondary Outcome Measures

Outcome Measure
Time Frame
duration of relief of pain or paresthesia
Time Frame: three month
three month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Usak State Hospital

Investigators

  • Principal Investigator: Ismail BIYIK, MD, Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

November 28, 2008

First Submitted That Met QC Criteria

December 1, 2008

First Posted (Estimate)

December 2, 2008

Study Record Updates

Last Update Posted (Estimate)

December 2, 2008

Last Update Submitted That Met QC Criteria

December 1, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B4ISM4350015-009/295

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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