Effects of Pregabalin, Duloxetine & Amitriptyline on Pain & Sleep
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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 |
- Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory. [ Time Frame: December 2008 ] [ Designated as safety issue: No ]
- 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) |
-
Drug: Pregabalin
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 |
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| 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 | |
| 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 Peripheral Nervous System Diseases Diabetic Neuropathies Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Neuromuscular Diseases Nervous System Diseases Diabetes Complications Amitriptyline Duloxetine Pregabalin Amitriptyline, perphenazine drug combination Antidepressive Agents, Tricyclic Antidepressive Agents |
Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Antipsychotic Agents |
ClinicalTrials.gov processed this record on May 16, 2013