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| 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: | 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) |
| 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) |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| Peripheral Neuropathy Center - Weill Cornell Medical College | |
| New York, New York, United States, 10022 | |
| Principal Investigator: | Thomas H Brannagan, MD | Weill Medical College of Cornell University |
More Information
| 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 |
|
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 |
