NCT00800527

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 2, 2008

Completed
Last Updated

December 2, 2008

Status Verified

November 1, 2008

Enrollment Period

7 months

First QC Date

November 28, 2008

Last Update Submit

December 1, 2008

Conditions

Chest PainParesthesia

Keywords

sternotomypainparesthesiaPoststernotomy chest painPoststernotomy chest paresthesia

Outcome Measures

Primary Outcomes (1)

  • Reduction of pain or paresthesia severity

    one month

Secondary Outcomes (1)

  • duration of relief of pain or paresthesia

    three month

Study Arms (2)

1

ACTIVE COMPARATOR

Gabapentin

Drug: Gabapentin

2

ACTIVE COMPARATOR

Diclofenac

Drug: Diclofenac

Interventions

GabapentinDRUG

Gabapentin 800 mg one a day up to 30 day

Also known as: Group-1: Gabapentin Arm
1
DiclofenacDRUG

Diclofenac 75 mg one a day up to 30 day

Also known as: Group-2: Diclofenac arm
2

Eligibility Criteria

Age15 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Poststernotomy chest pain and/or paresthesia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Usak State Hospital

Uşak, 64100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chest PainParesthesiaPain

Interventions

GabapentinDiclofenac

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSomatosensory DisordersSensation DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and ProteinsPhenylacetates

Study Officials

  • Ismail BIYIK, MD

    Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 28, 2008

First Posted

December 2, 2008

Study Start

November 1, 2007

Primary Completion

June 1, 2008

Study Completion

October 1, 2008

Last Updated

December 2, 2008

Record last verified: 2008-11

Locations

TU(1)