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

NCT00194909 | Completed Phase 4

• 1 other identifier: 1103-032
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetic Neuropathy

Outcome Measures

Primary Outcomes (1)

• Our primary outcome will be a reduction in the weekly average 11 point Likert pain scale (0 - no pain, 10 - worst possible pain) at 8 weeks.

Secondary Outcomes (1)

• Secondary outcomes will include the Rand-36 quality of life scale, McGill visual analogue scale (VAS) and a sleep interference scale.

Interventions

sildenafil (Viagra) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Pfizer: collaborator

Study Sites (1)

Peripheral Neuropathy Center - Weill Cornell Medical College

New York, New York, 10022, United States

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Thomas H Brannagan, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: August 1, 2004
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: March 25, 2008

Record last verified: 2008-03

Locations

US (1)