Effects of Pregabalin, Duloxetine & Amitriptyline on Pain & Sleep
Information source: University of Surrey
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus; Peripheral Neuropathies
Intervention: Pregabalin (Drug); Duloxetine (Drug); Amitriptyline (Drug)
Phase: Phase 2/Phase 3
Sponsored by: University of Surrey
Official(s) and/or principal investigator(s):
Professor AN Nicholson, Principal Investigator, Affiliation: University of Surrey
Dr D Kerr, Principal Investigator, Affiliation: Royal Bournemouth Hospital
Dr D Coppini, Principal Investigator, Affiliation: Poole General Hospital
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).
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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory.
Secondary outcome: Whether there has been an improvement in sleep continuity and subjective sleep, morning after cognitive and psychomotor performance, and quality of life (QoL).
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
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
Minimum age: 18 Years.
Maximum age: N/A.
1. 18 years of age or above
2. Have a diagnosis of Diabetes mellitus for at least a year
3. Agree not to smoke whilst resident in the CRC
4. Able to understand the patient information sheet and provide written informed consent
5. Score above 12 on the LANSS
6. Have neuropathic pain of diabetic origin
7. Score above 25 on MMSE
8. Willing to withdraw, under the guidance of their diabetologist, from any current pain
medication prior to their first visit to the sleep laboratory. Duration of withdrawal
will be at least equivalent to 5 half-lives and will be of a relevant duration given
the particular medication used.
1. There is evidence of an end stage disease of a major system (hepatic, renal,
respiratory, haematologic (PA), immunologic, cardiovascular, inflammatory,
rheumatology, active infections, peripheral vascular disease, untreated
2. There is evidence of a recent ischaemic event
3. There is evidence of recurrent and/or severe hypoglycemia requiring assistance in
last 3 years
4. Evidence of sleep pathology that would interfere with the assessment of treatment
(assessed on habituation night)
5. Currently receiving treatment for malignancy
6. Suffer from seizures including epilepsy
7. There is evidence of a history of dependence on or abuse of alcohol/recreational
8. Need to use a wheel chair (incompatible with studies in a sleep laboratory)
9. Involved in a clinical trial in last 3 months
10. Pregnant, lactating or inadequate contraception
11. Vision inadequate for the performance tests (as assessed at screening)
12. Colour Blind
13. Will not co-operate with study procedures
14. Will not give permission to inform GP
Locations and Contacts
Royal Bournemouth Hospital, Bournemouth, Dorset BH7 7DW, United Kingdom
Poole General Hospital, Poole, Dorset BH15 2JB, United Kingdom
University of Surrey Clinical Research Centre, Guildford, Surrey GU2 7XP, United Kingdom
Starting date: February 2007
Last updated: November 16, 2009