Status:
COMPLETED
An Open Label, Dose Finding Trial of Viagra for the Treatment of Neuropathic Pain (in Diabetes Mellitus)
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Pfizer
Conditions:
Diabetic Neuropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to study if sildenafil (Viagra) is effective in improving neuropathic pain. This will be an open label study at 3 doses of sildenafil (25 mg, 50 mg and 100 mg). If this st...
Detailed Description
Neuropathic pain is a common problem resulting from a diverse group of disorders including nerve injuries and neuropathies related to diabetes and other disorders. Pharmacologic agents are available s...
Eligibility Criteria
Inclusion
- Patients with signs and symptoms of a diabetic peripheral neuropathy as diagnosed by a neurologist with neuropathic pain will be included. The pain will have been present for at least 6 months. Patients may be on other medications for neuropathic pain such as anti-epileptic medications or tricyclic anti-depressants, however must be on a stable dose for 4 weeks prior to and during the study. Eligible patients must have a score of at least 40 on the VAS.
Exclusion
- Previous adverse reaction to viagra
- Blood pressure \< 90/50 or \> 170/100
- unstable angina
- retinitis pigmentosa,
- myocardial infarction stroke or life-threatening arrhythmia within the last 6 months
- hemoglobulin A1c \> 11
- HIV infection
- history of priapism
- hepatic or renal failure
- pregnancy
- current or past use of nitrates
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00194909
Start Date
August 1 2004
End Date
July 1 2006
Last Update
March 25 2008
Active Locations (1)
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1
Peripheral Neuropathy Center - Weill Cornell Medical College
New York, New York, United States, 10022