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Effects of Pregabalin, Duloxetine & Amitriptyline on Pain & Sleep

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ClinicalTrials.gov Identifier: NCT00370656
Recruitment Status : Completed
First Posted : September 1, 2006
Last Update Posted : November 17, 2009
Sponsor:
Information provided by:
University of Surrey

Tracking Information
First Submitted Date  ICMJE August 31, 2006
First Posted Date  ICMJE September 1, 2006
Last Update Posted Date November 17, 2009
Study Start Date  ICMJE February 2007
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2008)
Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory. [ Time Frame: December 2008 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2006)
Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory.
Change History Complete list of historical versions of study NCT00370656 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2006)
Whether there has been an improvement in sleep continuity and subjective sleep, morning after cognitive and psychomotor performance, and quality of life (QoL).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Pregabalin, Duloxetine & Amitriptyline on Pain & Sleep
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus
  • Peripheral Neuropathies
Intervention  ICMJE
  • Drug: Pregabalin
    capsule, 150mg bd, 300mg bd
  • Drug: Duloxetine
    Capsule, 60mg on, 60mg bd
  • Drug: Amitriptyline
    Capsule. 25 mg bd, 25 mg om and 50 mg on
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 31, 2006)
90
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00370656
Other Study ID Numbers  ICMJE CRC 235
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Professor Anthony Nicholson, University of Surrey
Study Sponsor  ICMJE University of Surrey
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Professor AN Nicholson University of Surrey
Principal Investigator: Dr D Kerr Royal Bournemouth Hospital
Principal Investigator: Dr D Coppini Poole General Hospital
PRS Account University of Surrey
Verification Date November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP