Diabetic Neuropathy Clinical Trial
Official title:
An Open Label, Dose Finding Trial of Viagra for the Treatment of Neuropathic Pain (in Diabetes Mellitus)
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04025320 -
The Effect of Intraneural Facilitation Therapy on Diabetic Patients With Peripheral Neuropathy
|
N/A | |
Completed |
NCT02659007 -
Less Neuropathy After Yoga- Managing Diabetic Neuropathy With Yoga
|
Phase 1 | |
Completed |
NCT01953757 -
A Nutritional Intervention for Diabetic Neuropathy (WCCR-DN2)
|
N/A | |
Completed |
NCT01707979 -
NIR- and Multifrequent Impedance Spectroscopy on the Skin in Type 1 Diabetes
|
N/A | |
Completed |
NCT00608439 -
Centella Asiatica Selected Triterpenes (CAST) for Diabetic Neuropathy
|
Phase 2 | |
Completed |
NCT00576277 -
Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AV411 in Neuropathic Pain
|
Phase 1/Phase 2 | |
Completed |
NCT00235443 -
A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy
|
Phase 2/Phase 3 | |
Completed |
NCT00830011 -
Cognitive Behavioral Therapy for Painful Diabetic Neuropathy
|
N/A | |
Completed |
NCT00931879 -
Lovaza® and Microvascular Function in Type 2 Diabetes
|
Phase 4 | |
Completed |
NCT00101426 -
Safety and Efficacy of AS-3201 in the Treatment of Diabetic Sensorimotor Polyneuropathy
|
Phase 3 | |
Completed |
NCT00190970 -
The Effect of Ruboxistaurin on Small Fiber Function
|
Phase 2 | |
Completed |
NCT00238550 -
Study of CBME in the Relief of Painful Diabetic Neuropathy
|
Phase 2 | |
Completed |
NCT05573685 -
Basket Study (CT-100-002) to Evaluate the Effects of a DiNaMoâ„¢ Component Training
|
N/A | |
Recruiting |
NCT02341261 -
Activity for Diabetic Polyneuropathy
|
N/A | |
Completed |
NCT01822925 -
Study of DA-9801 to Treat Diabetic Neuropathy
|
Phase 2 | |
Completed |
NCT01690962 -
A Nutritional Intervention for Diabetic Neuropathy
|
N/A | |
Terminated |
NCT00993018 -
A Study of Effectiveness and Safety of JNJ-42160443 in Patients With Diabetic Painful Neuropathy
|
Phase 2 | |
Withdrawn |
NCT02315235 -
The Peripheral Mobilized Mononuclear Cell-based Therapy in Patient With Diabetic Neuropathy
|
N/A | |
Completed |
NCT00496457 -
Efficacy Study With 500 mg QD of TRO19622 vs Placebo in Patients With Painful Peripheral Diabetic Neuropathy
|
Phase 2 | |
Recruiting |
NCT02606747 -
The Balance Control Mechanism of DPN Patients
|
N/A |