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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00194909
First received: September 12, 2005
Last updated: March 24, 2008
Last verified: March 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Dose Finding Trial of Viagra for the Treatment of Neuropathic Pain (in Diabetes Mellitus)

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetic Neuropathies
Neuralgia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Pain
Neurologic Manifestations
Signs and Symptoms
Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on August 28, 2014