An Open Label, Dose Finding Trial of Viagra for the Treatment of Neuropathic Pain (in Diabetes Mellitus)

Completed · Phase 4

Conditions studied: Diabetic Neuropathy

In brief

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 study suggests efficacy, the information will be used to plan a placebo controlled, double-blind study in the future.

Key facts

Study ID

NCT00194909

Run by

Weill Medical College of Cornell University

People needed

8

Starts

2004-08-01

Expected to finish

2006-07-01

Last updated by the study team

2008-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Peripheral Neuropathy Center - Weill Cornell Medical College — New York, New York, United States

Full record on ClinicalTrials.gov

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