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

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ClinicalTrials.gov Identifier: NCT00194909
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : March 25, 2008
Sponsor:
Collaborator:
Pfizer
Information provided by:
Weill Medical College of Cornell University

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.

Condition or disease Intervention/treatment Phase
Diabetic Neuropathy Drug: sildenafil (Viagra) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Dose Finding Trial of Viagra for the Treatment of Neuropathic Pain (in Diabetes Mellitus)
Study Start Date : August 2004
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine





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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00194909


Locations
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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
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Principal Investigator: Thomas H Brannagan, MD Weill Medical College of Cornell University

Additional Information:
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Responsible Party: Thomas Brannagan, MD Associate Professor of Clinical Neurology, Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT00194909    
Other Study ID Numbers: 1103-032
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: March 25, 2008
Last Verified: March 2008
Additional relevant MeSH terms:
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Neuralgia
Diabetic Neuropathies
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Diabetes Complications
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents