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| Sponsored by: |
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 |
| Estimated Enrollment: | 90 |
| Study Start Date: | February 2007 |
| Estimated Study Completion Date: | May 2009 |
| Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
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:
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:
Contacts and Locations| Contact: Professor AN Nicholson | 01483 683719 | A.Nicholson@Surrey.ac.uk |
| Contact: Miss J Arthur | 01483 689788 | J.Arthur@surrey.ac.uk |
| United Kingdom, Dorset | |
| Royal Bournemouth Hospital | Recruiting |
| Bournemouth, Dorset, United Kingdom, BH7 7DW | |
| Contact: Dr D Kerr 01202-704603 David.Kerr@rbch.nhs.uk | |
| Contact: D Hill 01202 704603 Dawn.Hill@rbch.nhs.uk | |
| Poole General Hospital | Recruiting |
| Poole, Dorset, United Kingdom, BH15 2JB | |
| Contact: Dr D Coppini 01202 442399 David.Coppini@poole.nhs.uk | |
| Contact: P Bowden 01202 442399 Paula.Bowden@poole.nhs.uk | |
| United Kingdom, Surrey | |
| University of Surrey Clinical Research Centre | Not yet recruiting |
| Guildford, Surrey, United Kingdom, GU2 7XP | |
| Contact: Professor AN Nicholson 01483 683719 A.Nicholson@Surrey.ac.uk | |
| Contact: Miss J Arthur 01483 689788 J.Arthur@Surrey.ac.uk | |
| 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
| Responsible Party: | University of Surrey ( Professor Anthony Nicholson ) |
| Study ID Numbers: | CRC 235 |
| Study First Received: | August 31, 2006 |
| Last Updated: | February 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00370656 History of Changes |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Diabetic Peripheral Neuropathy |
|
Dopamine Uptake Inhibitors Neurotransmitter Agents Adrenergic Agents Psychotropic Drugs Pain Duloxetine Dopamine Neuromuscular Diseases Analgesics Metabolic Disorder Diabetes Complications Antidepressive Agents Metabolic Diseases Diabetic Neuropathies |
Diabetes Mellitus Pregabalin Endocrine System Diseases Serotonin Uptake Inhibitors Serotonin Antidepressive Agents, Tricyclic Analgesics, Non-Narcotic Peripheral Nervous System Diseases Amitriptyline Dopamine Agents Endocrinopathy Peripheral Nervous System Agents Glucose Metabolism Disorders Anticonvulsants |
|
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 |
