Effects of Pregabalin, Duloxetine & Amitriptyline on Pain & Sleep

November 16, 2009 updated by: University of Surrey

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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

Enrollment (Anticipated)

90

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Dorset
      • Bournemouth, Dorset, United Kingdom, BH7 7DW
        • Royal Bournemouth Hospital
      • Poole, Dorset, United Kingdom, BH15 2JB
        • Poole General Hospital
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XP
        • University of Surrey Clinical Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory.
Time Frame: December 2008
December 2008

Secondary Outcome Measures

Outcome Measure
Time Frame
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
December 2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Surrey

Investigators

  • Principal Investigator: Professor AN Nicholson, University of Surrey
  • Principal Investigator: Dr D Kerr, Royal Bournemouth Hospital
  • Principal Investigator: Dr D Coppini, Poole General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

August 31, 2006

First Submitted That Met QC Criteria

August 31, 2006

First Posted (Estimate)

September 1, 2006

Study Record Updates

Last Update Posted (Estimate)

November 17, 2009

Last Update Submitted That Met QC Criteria

November 16, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRC 235

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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