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Trial record 40 of 135 for:    AMITRIPTYLINE

Effects of Pregabalin, Duloxetine & Amitriptyline on Pain & Sleep

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00370656
Recruitment Status : Completed
First Posted : September 1, 2006
Last Update Posted : November 17, 2009
Information provided by:
University of Surrey

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).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Peripheral Neuropathies Drug: Pregabalin Drug: Duloxetine Drug: Amitriptyline Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : February 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Intervention Details:
  • 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

Primary Outcome Measures :
  1. Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory. [ Time Frame: December 2008 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00370656

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United Kingdom
Royal Bournemouth Hospital
Bournemouth, Dorset, United Kingdom, BH7 7DW
Poole General Hospital
Poole, Dorset, United Kingdom, BH15 2JB
University of Surrey Clinical Research Centre
Guildford, Surrey, United Kingdom, GU2 7XP
Sponsors and Collaborators
University of Surrey
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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 automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Professor Anthony Nicholson, University of Surrey Identifier: NCT00370656     History of Changes
Other Study ID Numbers: CRC 235
First Posted: September 1, 2006    Key Record Dates
Last Update Posted: November 17, 2009
Last Verified: November 2009
Keywords provided by University of Surrey:
Diabetic Peripheral Neuropathy
Additional relevant MeSH terms:
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Amitriptyline, perphenazine drug combination
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Duloxetine Hydrochloride
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Antidepressive Agents
Dopamine Agents
Antidepressive Agents, Tricyclic
Analgesics, Non-Narcotic
Adrenergic Uptake Inhibitors
Adrenergic Agents
Antipsychotic Agents