Effects of Pregabalin, Duloxetine & Amitriptyline on Pain & Sleep

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Surrey
• Treatments: Amitriptyline; Amitriptyline, perphenazine drug combination; Duloxetine Hydrochloride; Pregabalin

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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 endocrine(hypothyroid)

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 drugs

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