A Phase 4 interventional study of Gabapentin and Diclofenac in Chest Pain and Paresthesia, sponsored by Usak State Hospital. Completed at 1 site in Turkey. Open to participants aged 15 Years to 85 Years. Per ClinicalTrials.gov, last updated 2008-12-02.
Sponsored by Usak State Hospital · Phase 4, Interventional, and Treatment
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.
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.
388 studies on the registry are indexed under Chest Pain; 64 are open to participants now.
This study's enrollment of 110 is below the median of 129 across 204 interventional studies indexed under Chest Pain.
Browse Chest Pain studies →Usak State Hospital is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Gabapentin
Drug: Gabapentin
Diclofenac
Drug: Diclofenac
Gabapentin 800 mg one a day up to 30 day
Also known as: Group-1: Gabapentin Arm
Diclofenac 75 mg one a day up to 30 day
Also known as: Group-2: Diclofenac arm
Reduction of pain or paresthesia severity
Time frame: one month
duration of relief of pain or paresthesia
Time frame: three month
The record gives a start of Nov 2007, a primary completion of Jun 2008 and a completion of Oct 2008. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2008. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Gabapentin · Diclofenac
Usak State Hospital