Effects of Pregabalin, Duloxetine & Amitriptyline on Pain & Sleep

This study has been completed.
Sponsor:
Information provided by:
University of Surrey
ClinicalTrials.gov Identifier:
NCT00370656
First received: August 31, 2006
Last updated: November 16, 2009
Last verified: November 2009
  Purpose

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 Intervention Phase
Diabetes Mellitus
Peripheral Neuropathies
Drug: Pregabalin
Drug: Duloxetine
Drug: Amitriptyline
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of Surrey:

Primary Outcome Measures:
  • Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory. [ Time Frame: December 2008 ] [ Designated as safety issue: No ]

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). [ Time Frame: December 2008 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: February 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00370656

Locations
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
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
  More Information

No publications provided by University of Surrey

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Anthony Nicholson, University of Surrey
ClinicalTrials.gov Identifier: NCT00370656     History of Changes
Other Study ID Numbers: CRC 235
Study First Received: August 31, 2006
Last Updated: November 16, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Surrey:
Diabetic Peripheral Neuropathy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Complications
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Nervous System Diseases
Neuromuscular Diseases
Amitriptyline
Amitriptyline, perphenazine drug combination
Duloxetine
Pregabalin
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Analgesics, Non-Narcotic
Anticonvulsants
Antidepressive Agents
Antidepressive Agents, Tricyclic
Antipsychotic Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents

ClinicalTrials.gov processed this record on October 30, 2014