Effects of Pregabalin, Duloxetine & Amitriptyline on Pain & Sleep - Full Text View

Sponsor:	University of Surrey
Information provided by:	University of Surrey
ClinicalTrials.gov Identifier:	NCT00370656

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 II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment
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:

MedlinePlus related topics: Diabetes Peripheral Nerve Disorders

Drug Information available for: Amitriptyline Duloxetine Duloxetine hydrochloride Pregabalin Amitriptyline hydrochloride Triavil

U.S. FDA Resources

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:

capsule, 150mg bd, 300mg bd

Capsule, 60mg on, 60mg bd

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:

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

Contacts and Locations

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

Locations

United Kingdom, Dorset
Royal Bournemouth Hospital
Bournemouth, Dorset, United Kingdom, BH7 7DW
Poole General Hospital
Poole, Dorset, United Kingdom, BH15 2JB
United Kingdom, Surrey
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

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

Keywords provided by University of Surrey:

Diabetic Peripheral Neuropathy

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Duloxetine
Neuromuscular Diseases
Sensory System Agents
Therapeutic Uses
Analgesics
Diabetes Complications
Antidepressive Agents

Metabolic Diseases
Diabetic Neuropathies
Nervous System Diseases
Diabetes Mellitus
Pregabalin
Endocrine System Diseases
Serotonin Uptake Inhibitors
Pharmacologic Actions
Antidepressive Agents, Tricyclic
Serotonin Agents
Analgesics, Non-Narcotic
Peripheral Nervous System Diseases
Amitriptyline
Dopamine Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010