Effects of Pregabalin, Duloxetine & Amitriptyline on Pain & Sleep

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00370656
• Other study ID #: CRC 235
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 31, 2006
• Last updated: November 16, 2009
• Start date: February 2007
• Est. completion date: May 2009

Study information

• Verified date: November 2009
• Source: University of Surrey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Neuropathies
• Peripheral Nervous System Diseases
• Peripheral Neuropathies

Intervention

Drug:
• Pregabalin
capsule, 150mg bd, 300mg bd
• Duloxetine
Capsule, 60mg on, 60mg bd
• Amitriptyline
Capsule. 25 mg bd, 25 mg om and 50 mg on

Locations

Country	Name	City	State
United Kingdom	Royal Bournemouth Hospital	Bournemouth	Dorset
United Kingdom	University of Surrey Clinical Research Centre	Guildford	Surrey
United Kingdom	Poole General Hospital	Poole	Dorset

Sponsors (1)

Lead Sponsor	Collaborator
University of Surrey

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory.		December 2008	No
Secondary	Whether there has been an improvement in sleep continuity and subjective sleep, morning after cognitive and psychomotor performance, and quality of life (QoL).		December 2008	No