Status:
COMPLETED
Effects of Pregabalin, Duloxetine & Amitriptyline on Pain & Sleep
Lead Sponsor:
University of Surrey
Conditions:
Diabetes Mellitus
Peripheral Neuropathies
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 (BP...
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 concer...
Eligibility Criteria
Inclusion
- 18 years of age or above
- Have a diagnosis of Diabetes mellitus for at least a year
- Agree not to smoke whilst resident in the CRC
- Able to understand the patient information sheet and provide written informed consent
- Score above 12 on the LANSS
- Have neuropathic pain of diabetic origin
- Score above 25 on MMSE
- 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.
Exclusion
- 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 endocrine(hypothyroid)
- There is evidence of a recent ischaemic event
- There is evidence of recurrent and/or severe hypoglycemia requiring assistance in last 3 years
- Evidence of sleep pathology that would interfere with the assessment of treatment (assessed on habituation night)
- Currently receiving treatment for malignancy
- Suffer from seizures including epilepsy
- There is evidence of a history of dependence on or abuse of alcohol/recreational drugs
- Need to use a wheel chair (incompatible with studies in a sleep laboratory)
- Involved in a clinical trial in last 3 months
- Pregnant, lactating or inadequate contraception
- Vision inadequate for the performance tests (as assessed at screening)
- Colour Blind
- Will not co-operate with study procedures
- Will not give permission to inform GP
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2009
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00370656
Start Date
February 1 2007
End Date
May 1 2009
Last Update
November 17 2009
Active Locations (3)
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1
Royal Bournemouth Hospital
Bournemouth, Dorset, United Kingdom, BH7 7DW
2
Poole General Hospital
Poole, Dorset, United Kingdom, BH15 2JB
3
University of Surrey Clinical Research Centre
Guildford, Surrey, United Kingdom, GU2 7XP