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Effects of Pregabalin, Duloxetine & Amitriptyline on Pain & Sleep

Primary Purpose

Diabetes Mellitus, Peripheral Neuropathies

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Pregabalin
Duloxetine
Amitriptyline
Sponsored by
University of Surrey
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetic Peripheral Neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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

Sites / Locations

  • Royal Bournemouth Hospital
  • Poole General Hospital
  • University of Surrey Clinical Research Centre

Outcomes

Primary Outcome Measures

Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory.

Secondary Outcome Measures

Whether there has been an improvement in sleep continuity and subjective sleep, morning after cognitive and psychomotor performance, and quality of life (QoL).

Full Information

First Posted
August 31, 2006
Last Updated
November 16, 2009
Sponsor
University of Surrey
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1. Study Identification

Unique Protocol Identification Number
NCT00370656
Brief Title
Effects of Pregabalin, Duloxetine & Amitriptyline on Pain & Sleep
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 Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Surrey

4. Oversight

5. Study Description

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 (BPI).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Peripheral Neuropathies
Keywords
Diabetic Peripheral Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
capsule, 150mg bd, 300mg bd
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Intervention Description
Capsule, 60mg on, 60mg bd
Intervention Type
Drug
Intervention Name(s)
Amitriptyline
Intervention Description
Capsule. 25 mg bd, 25 mg om and 50 mg on
Primary Outcome Measure Information:
Title
Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory.
Time Frame
December 2008
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor AN Nicholson
Organizational Affiliation
University of Surrey
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr D Kerr
Organizational Affiliation
Royal Bournemouth Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr D Coppini
Organizational Affiliation
Poole General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
State/Province
Dorset
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Poole General Hospital
City
Poole
State/Province
Dorset
ZIP/Postal Code
BH15 2JB
Country
United Kingdom
Facility Name
University of Surrey Clinical Research Centre
City
Guildford
State/Province
Surrey
ZIP/Postal Code
GU2 7XP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22991449
Citation
Boyle J, Eriksson ME, Gribble L, Gouni R, Johnsen S, Coppini DV, Kerr D. Randomized, placebo-controlled comparison of amitriptyline, duloxetine, and pregabalin in patients with chronic diabetic peripheral neuropathic pain: impact on pain, polysomnographic sleep, daytime functioning, and quality of life. Diabetes Care. 2012 Dec;35(12):2451-8. doi: 10.2337/dc12-0656. Epub 2012 Sep 18.
Results Reference
derived

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Effects of Pregabalin, Duloxetine & Amitriptyline on Pain & Sleep

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