An Open Label, Dose Finding Trial of Viagra for the Treatment of Neuropathic Pain (in Diabetes Mellitus)
Information source: Weill Medical College of Cornell University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Neuropathy
Intervention: sildenafil (Viagra) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Weill Medical College of Cornell University Official(s) and/or principal investigator(s):
Thomas H Brannagan, MD, Principal Investigator, Affiliation: Weill Medical College of Cornell University
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.
Clinical Details
Official title: An Open Label, Dose Finding Trial of Viagra for the Treatment of Neuropathic Pain (in Diabetes Mellitus)
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: 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: Secondary outcomes will include the Rand-36 quality of life scale, McGill visual analogue scale (VAS) and a sleep interference scale.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Peripheral Neuropathy Center - Weill Cornell Medical College, New York, New York 10022, United States
Additional Information
Starting date: August 2004
Ending date: July 2006
Last updated: March 24, 2008
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