Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00370656
Status:
COMPLETED
Last Update Posted:
2009-11-17
First Post:
2006-08-31
Brief Title:
Effects of Pregabalin Duloxetine Amitriptyline on Pain Sleep
Sponsor:
University of Surrey
Organization:
University of Surrey
Study Overview
Official Title:
A Double-blind Randomised Parallel Groups Investigation Into the Effects of Pregabalin Duloxetine and Amitriptyline on Aspects of Pain Sleep and Next Day Performance in Patients Suffering From Diabetic Peripheral Neuropathy
Status:
COMPLETED
Status Verified Date:
2009-11
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 assess the effectiveness of pregabalin duloxetine and amitriptyline compared with placebo in reducing pain in diabetic patients as assessed by Brief Pain Inventory BPI
Detailed Description:
Little is understood concerning the interaction of pain with sleep Pain may disrupt sleep leading to daytime sleepiness and poor sleep can increase the perception of pain There is uncertainty concerning the most effective way in which medication could be used to ease pain and poor sleep in patients such as those with diabetic peripheral neuropathy Various drugs have been tried or proposed and these include amitriptyline pregabalin and duloxetine
Amitriptyline is believed to relieve pain and improve sleep though there is little evidence of its beneficial effects on sleep Furthermore even at low doses it affects reaction time attention memory information processing
In two studies with duloxetine it has been shown to significantly reduce pain compared with placebo although little data are available on the usefulness of this compound in the management of pain with poor sleep
Pregabalin has been shown to be effective in reducing pain and therefore improving sleep It has also been demonstrated that it has limited potential to affect daytime cognition In another study gabapentin a compound structurally related to pregabalin demonstrated superior efficacy in the management of pain compared to amitriptyline
Therefore this study will assess the effectiveness of pregabalin duloxetine and amitriptyline compared with placebo in reducing pain associated with diabetes and poor sleep
As the incidence of diabetes is predicted to increase in future years and as a consequence so will the cases of diabetic peripheral neuropathy DPN this research will serve to provide essential information on sleep and DPN which will be beneficial now and in the future
Amitriptyline is believed to relieve pain and improve sleep though there is little evidence of its beneficial effects on sleep Furthermore even at low doses it affects reaction time attention memory information processing
In two studies with duloxetine it has been shown to significantly reduce pain compared with placebo although little data are available on the usefulness of this compound in the management of pain with poor sleep
Pregabalin has been shown to be effective in reducing pain and therefore improving sleep It has also been demonstrated that it has limited potential to affect daytime cognition In another study gabapentin a compound structurally related to pregabalin demonstrated superior efficacy in the management of pain compared to amitriptyline
Therefore this study will assess the effectiveness of pregabalin duloxetine and amitriptyline compared with placebo in reducing pain associated with diabetes and poor sleep
As the incidence of diabetes is predicted to increase in future years and as a consequence so will the cases of diabetic peripheral neuropathy DPN this research will serve to provide essential information on sleep and DPN which will be beneficial now and 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