Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194909
Status:
COMPLETED
Last Update Posted:
2008-03-25
First Post:
2005-09-12
Brief Title:
An Open Label Dose Finding Trial of Viagra for the Treatment of Neuropathic Pain in Diabetes Mellitus
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
An Open Label Dose Finding Trial of Viagra for the Treatment of Neuropathic Pain in Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None