Effects of Pregabalin, Duloxetine & Amitriptyline on Pain & Sleep
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|ClinicalTrials.gov Identifier: NCT00370656|
Recruitment Status : Completed
First Posted : September 1, 2006
Last Update Posted : November 17, 2009
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Peripheral Neuropathies||Drug: Pregabalin Drug: Duloxetine Drug: Amitriptyline||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2009|
- Drug: Pregabalin
capsule, 150mg bd, 300mg bd
- Drug: Duloxetine
Capsule, 60mg on, 60mg bd
- Drug: Amitriptyline
Capsule. 25 mg bd, 25 mg om and 50 mg on
- Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory. [ Time Frame: December 2008 ]
- Whether there has been an improvement in sleep continuity and subjective sleep, morning after cognitive and psychomotor performance, and quality of life (QoL). [ Time Frame: December 2008 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00370656
|Royal Bournemouth Hospital|
|Bournemouth, Dorset, United Kingdom, BH7 7DW|
|Poole General Hospital|
|Poole, Dorset, United Kingdom, BH15 2JB|
|University of Surrey Clinical Research Centre|
|Guildford, Surrey, United Kingdom, GU2 7XP|
|Principal Investigator:||Professor AN Nicholson||University of Surrey|
|Principal Investigator:||Dr D Kerr||Royal Bournemouth Hospital|
|Principal Investigator:||Dr D Coppini||Poole General Hospital|