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

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborator: Pfizer
• Treatments: Sildenafil Citrate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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