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

Sponsor:	Weill Medical College of Cornell University
Collaborator:	Pfizer
Information provided by:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00194909

Purpose

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.

Condition	Intervention	Phase
Diabetic Neuropathy	Drug: sildenafil (Viagra)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open Label, Dose Finding Trial of Viagra for the Treatment of Neuropathic Pain (in Diabetes Mellitus)

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetic Nerve Problems

Drug Information available for: Sildenafil Sildenafil citrate

U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:

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 Outcome Measures:

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

Enrollment:	8
Study Start Date:	August 2004
Study Completion Date:	July 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

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 such as gabapentin, which can successfully treat many patients. For many however there is inadequate treatment available, due to lack of efficacy and poor tolerability and the need for new pharmacologic agents is recognized.

We propose to study if sildenafil is effective in improving neuropathic pain, in patients with diabetes mellitus. 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 will include the Rand-36 quality of life scale, McGill visual analogue scale (VAS) and a sleep interference scale.

This will be an open label study at 3 doses of sildenafil (25 mg, 50 mg and 100 mg). Patients will begin at 25 mg at night for 1 week. If pain continues, the dose will be increased to 50 mg at night for 1 week. If pain continues the dose will be increased to 100 mg at night. Subjects will be on the medication for 8 weeks. If this study suggests efficacy, the information will be used to plan a placebo controlled, double-blind study in the future.

We propose to study if sildenafil is effective in improving neuropathic pain. 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 will include the Rand-36 quality of life scale, McGill visual analogue scale (VAS) and a sleep interference scale.

This will be an open label study at 3 doses of sildenafil (25 mg, 50 mg and 100 mg). Patients will begin at 25 mg at night for 1 week. If pain continues, the dose will be increased to 50 mg at night for 1 week. If pain continues the dose will be increased to 100 mg at night. Subjects will be on the medication for 8 weeks. If this study suggests efficacy, the information will be used to plan a placebo controlled, double-blind study in the future.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00194909

Locations

United States, New York
Peripheral Neuropathy Center - Weill Cornell Medical College
New York, New York, United States, 10022

Sponsors and Collaborators

Weill Medical College of Cornell University

Pfizer

Investigators

Principal Investigator:

Thomas H Brannagan, MD

Weill Medical College of Cornell University

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Weill Cornell Medical College ( Thomas Brannagan, MD Associate Professor of Clinical Neurology )
Study ID Numbers:	1103-032
Study First Received:	September 12, 2005
Last Updated:	March 24, 2008
ClinicalTrials.gov Identifier:	NCT00194909 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Vasodilator Agents
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Diabetic Neuropathies
Nervous System Diseases
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors
Sildenafil

Cardiovascular Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Neuromuscular Diseases
Peripheral Nervous System Diseases
Therapeutic Uses
Glucose Metabolism Disorders
Diabetes Complications

ClinicalTrials.gov processed this record on November 27, 2009